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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02391805
Registration number
NCT02391805
Ethics application status
Date submitted
6/03/2015
Date registered
18/03/2015
Date last updated
6/06/2018
Titles & IDs
Public title
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
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Scientific title
A Multiple-Center, Randomized, Partially Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Effects of 12-Week Treatment With RO6864018 in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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NP28938
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Entecavir
Treatment: Drugs - Placebo
Treatment: Drugs - RO6864018
Treatment: Drugs - Tenofovir
Placebo comparator: Placebo, Every Other Day (QOD) - Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Placebo comparator: Placebo, Once a Week (QWk) - Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Experimental: RO6864018, 1200 milligrams (mg) QOD - RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Experimental: RO6864018, 1200 mg QWk - RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Experimental: RO6864018, 800 mg QOD - RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Experimental: RO6864018, 800 mg QWk - RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Treatment: Drugs: Entecavir
Entecavir will be administered as per local labeling.
Treatment: Drugs: Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
Treatment: Drugs: RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Treatment: Drugs: Tenofovir
Tenofovir will be administered as per local labeling.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety: Percentage of Participants with Adverse Events
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Assessment method [1]
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Timepoint [1]
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Baseline up to approximately 36 weeks
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Secondary outcome [1]
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Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts
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Assessment method [1]
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Timepoint [1]
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Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [2]
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Pharmacodynamics: Peripheral Blood Levels of IFN-Alpha in QWk Dosing Cohorts
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Assessment method [2]
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Timepoint [2]
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Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [3]
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Pharmacodynamics: Peripheral Blood Levels of IFN-Gamma-Induced Protein (IP)-10 in QOD Dosing Cohorts
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Assessment method [3]
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Timepoint [3]
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Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [4]
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Pharmacodynamics: Peripheral Blood Levels of IP-10 in QWk Dosing Cohorts
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Assessment method [4]
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Timepoint [4]
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Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [5]
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Efficacy: Quantitative HBV Deoxyribonucleic Acid (DNA) Level in QOD Dosing Cohorts
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Assessment method [5]
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Timepoint [5]
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Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up; and at any point that breakthrough occurs (up to 36 weeks)
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Secondary outcome [6]
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Efficacy: Quantitative HBV DNA Level in QWk Dosing Cohorts
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Assessment method [6]
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Timepoint [6]
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Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up; and at any point that breakthrough occurs (up to 36 weeks)
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Secondary outcome [7]
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Efficacy: Quantitative Hepatitis B Surface Antigen (HBsAg) Level in QOD Dosing Cohorts
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Assessment method [7]
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Timepoint [7]
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Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [8]
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Efficacy: Quantitative HBsAg Level in QWk Dosing Cohorts
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Assessment method [8]
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Timepoint [8]
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Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [9]
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Efficacy: Percentage of Participants with Loss of HBsAg in QOD Dosing Cohorts
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Assessment method [9]
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Timepoint [9]
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Baseline; on Day 7 of Week 12; then at Week 36 during follow-up
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Secondary outcome [10]
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Efficacy: Percentage of Participants with Loss of HBsAg in QWk Dosing Cohorts
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Assessment method [10]
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Timepoint [10]
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Baseline; on Day 7 of Week 12; then at Week 36 during follow-up
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Secondary outcome [11]
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Efficacy: Percentage of Participants with Loss of Hepatitis B Envelope Antigen (HBeAg) in QOD Dosing Cohorts
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Assessment method [11]
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Timepoint [11]
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Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [12]
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Efficacy: Percentage of Participants with Loss of HBeAg in QWk Dosing Cohorts
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Assessment method [12]
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Timepoint [12]
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Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [13]
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Efficacy: Percentage of Participants with HBsAg Seroconversion in QOD Dosing Cohorts
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Assessment method [13]
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HBsAg Seroconversion = antibody to HBsAg (Anti-HBs) Positive Status and Loss of HBsAg
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Timepoint [13]
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Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Week 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [14]
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Efficacy: Percentage of Participants with HBsAg Seroconversion in QWk Dosing Cohorts
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Assessment method [14]
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HBsAg Seroconversion = anti-HBs Positive Status and Loss of HBsAg
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Timepoint [14]
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Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [15]
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Efficacy: Percentage of Participants with HBeAg Seroconversion in QOD Dosing Cohorts
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Assessment method [15]
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HBeAg Seroconversion = antibody to HBeAg (anti-HBe) Positive Status and Loss of HBeAg
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Timepoint [15]
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Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Week 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [16]
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Efficacy: Percentage of Participants with HBeAg Seroconversion in QWk Dosing Cohorts
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Assessment method [16]
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HBeAg Seroconversion = anti-HBe Positive Status and Loss of HBeAg
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Timepoint [16]
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Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [17]
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Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of RO6864018 Metabolite in QOD Dosing Cohorts
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Assessment method [17]
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Timepoint [17]
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Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
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Secondary outcome [18]
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Pharmacokinetics: Cmax of RO6864018 Metabolite in QWk Dosing Cohorts
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Assessment method [18]
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0
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Timepoint [18]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Secondary outcome [19]
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Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of RO6864018 Metabolite in QOD Dosing Cohorts
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Assessment method [19]
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0
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Timepoint [19]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
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Secondary outcome [20]
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0
Pharmacokinetics: Tmax of RO6864018 Metabolite in QWk Dosing Cohorts
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Assessment method [20]
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0
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Timepoint [20]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Secondary outcome [21]
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Pharmacokinetics: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of RO6864018 Metabolite in QOD Dosing Cohorts
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Assessment method [21]
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0
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Timepoint [21]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
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Secondary outcome [22]
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0
Pharmacokinetics: AUCinf of RO6864018 Metabolite in QWk Dosing Cohorts
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Assessment method [22]
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0
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Timepoint [22]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Secondary outcome [23]
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Pharmacokinetics: Area Under the Plasma Concentration-Time Curve up to the Last Measurable Concentration (AUClast) of RO6864018 Metabolite in QOD Dosing Cohorts
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Assessment method [23]
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0
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Timepoint [23]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
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Secondary outcome [24]
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0
Pharmacokinetics: AUClast of RO6864018 Metabolite in QWk Dosing Cohorts
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Assessment method [24]
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0
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Timepoint [24]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Secondary outcome [25]
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Pharmacokinetics: Half-life (t1/2) of RO6864018 Metabolite in QOD Dosing Cohorts
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Assessment method [25]
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Timepoint [25]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
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Secondary outcome [26]
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0
Pharmacokinetics: T1/2 of RO6864018 Metabolite in QWk Dosing Cohorts
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Assessment method [26]
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0
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Timepoint [26]
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0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Secondary outcome [27]
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Pharmacodynamics: Peripheral Blood Levels of Neopterin in QOD Dosing Cohorts
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Assessment method [27]
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0
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Timepoint [27]
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0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [28]
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0
Pharmacodynamics: Peripheral Blood Levels of Neopterin in QWk Dosing Cohorts
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Assessment method [28]
0
0
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Timepoint [28]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [29]
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Pharmacodynamics: Peripheral Blood Levels of Tumor Necrosis Factor (TNF)-Alpha in QOD Dosing Cohorts
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Assessment method [29]
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0
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Timepoint [29]
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0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [30]
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0
Pharmacodynamics: Peripheral Blood Levels of TNF-alpha in QWk Dosing Cohorts
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Assessment method [30]
0
0
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Timepoint [30]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [31]
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0
Pharmacodynamics: Peripheral Blood Levels of Interleukin (IL)-6 in QOD Dosing Cohorts
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Assessment method [31]
0
0
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Timepoint [31]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [32]
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0
Pharmacodynamics: Peripheral Blood Levels of IL-6 in QWk Dosing Cohorts
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Assessment method [32]
0
0
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Timepoint [32]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [33]
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0
Pharmacodynamics: Peripheral Blood Levels of IL-10 in QOD Dosing Cohorts
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Assessment method [33]
0
0
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Timepoint [33]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [34]
0
0
Pharmacodynamics: Peripheral Blood Levels of IL-10 in QWk Dosing Cohorts
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Assessment method [34]
0
0
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Timepoint [34]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [35]
0
0
Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QOD Dosing Cohorts
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Assessment method [35]
0
0
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Timepoint [35]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [36]
0
0
Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QWk Dosing Cohorts
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Assessment method [36]
0
0
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Timepoint [36]
0
0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [37]
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0
Efficacy: Percentage of Participants with Development of Anti-HBe in QOD Dosing Cohorts
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Assessment method [37]
0
0
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Timepoint [37]
0
0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [38]
0
0
Efficacy: Percentage of Participants with Development of Anti-HBe in QWk Dosing Cohorts
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Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [39]
0
0
Efficacy: Percentage of Participants with Development of Anti-HBs in QOD Dosing Cohorts
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Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [40]
0
0
Efficacy: Percentage of Participants with Development of Anti-HBs in QWk Dosing Cohorts
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Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [41]
0
0
Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QWk Cohorts
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Assessment method [41]
0
0
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Timepoint [41]
0
0
QWk: Baseline; pre-dose (0 hours) and post-dose (6 and 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12, and Day 7 of Week 12; then Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [42]
0
0
Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QOD Cohorts
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Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Baseline; pre-dose; post-dose (6 and 24 hours) on Days 1, 3, and 7 for Week 1, Day 1 of Weeks 3, 5, 7, Day 6 of Week 12; then Weeks 16, 20, 24, 28, 32, 36 during follow-up
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Secondary outcome [43]
0
0
Pharmacodynamics: Percentage of T Cells, B Cells, and NK Cells (TBNK)
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Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
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Secondary outcome [44]
0
0
Pharmacodynamics: Percentage of Myeloid Cells
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Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
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Secondary outcome [45]
0
0
Pharmacodynamics: Percentage of Plasmacytoid Dendritic Cells
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Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
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Secondary outcome [46]
0
0
Pharmacokinetics: Cmax of Entecavir in QWk Dosing Cohorts
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Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Query!
Secondary outcome [47]
0
0
Pharmacokinetics: AUCinf of Entecavir in QWk Dosing Cohorts
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Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
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Eligibility
Key inclusion criteria
* Chronic hepatitis B infection
* Positive test for HBsAg for more than 6 months prior to randomization
* HBsAg titer greater than or equal to (>/=) 250 international units per milliliter (IU/mL) at Screening
* Treatment with any nucleoside/nucleotide analogue for >/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization
* HBV DNA less than (<) 90 IU/mL for at least the preceding 6 months
* HBeAg positive at randomization and for at least 6 months prior to randomization
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnant or lactating women
* Documented history of HBV genotype D
* History or other evidence of bleeding from esophageal varices
* History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease
* Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Documented history of hepatitis D infection
* History of or suspicion of hepatocellular carcinoma
* History of immunologically mediated disease
* History of organ transplantation
* History of thyroid disease
* Significant acute infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/10/2017
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Hong Kong
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N.t.
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Korea, Republic of
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State/province [3]
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Seoul
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Malaysia
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Ampang
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Malaysia
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Batu Caves
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Malaysia
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State/province [6]
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Kuala Lumpur
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New Zealand
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State/province [7]
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Grafton
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New Zealand
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Hamilton
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Singapore
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Singapore
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Taiwan
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State/province [10]
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Kaohsiung
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Country [11]
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Taiwan
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State/province [11]
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Taipei City
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Country [12]
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Taiwan
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State/province [12]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.
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Trial website
https://clinicaltrials.gov/study/NCT02391805
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02391805
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