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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01826981




Registration number
NCT01826981
Ethics application status
Date submitted
1/04/2013
Date registered
9/04/2013

Titles & IDs
Public title
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Scientific title
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
Secondary ID [1] 0 0
GS-US-337-0122
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LDV/SOF
Treatment: Drugs - SOF
Treatment: Drugs - RBV
Treatment: Drugs - Peg-IFN
Treatment: Drugs - GS-9669
Treatment: Drugs - VEL

Experimental: Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment) - LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study

Experimental: Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment) - SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study

Experimental: Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease) - LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis

Experimental: Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease) - LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis

Experimental: Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) - LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection

Experimental: Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) - LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection

Experimental: Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) - LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection

Experimental: Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) - LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection

Experimental: Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B) - LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis

Experimental: Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic) - SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Experimental: Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic) - SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Experimental: Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic) - SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Experimental: Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic) - SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Experimental: Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment) - LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study

Experimental: Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection) - LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection


Treatment: Drugs: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

Treatment: Drugs: SOF
SOF 400 mg tablet administered orally once daily

Treatment: Drugs: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Treatment: Drugs: Peg-IFN
pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

Treatment: Drugs: GS-9669
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

Treatment: Drugs: VEL
Velpatasvir (VEL) tablet(s) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Timepoint [2] 0 0
Up to 24 weeks plus 30 days
Secondary outcome [1] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Timepoint [1] 0 0
Weeks 1 and 2
Secondary outcome [2] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Timepoint [2] 0 0
Weeks 4, 6, and 8
Secondary outcome [3] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Timepoint [3] 0 0
Week 10
Secondary outcome [4] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Timepoint [5] 0 0
Weeks 16, 20, and 24
Secondary outcome [6] 0 0
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
Timepoint [6] 0 0
Posttreatment Weeks 2, 4, 8, and 24
Secondary outcome [7] 0 0
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
Timepoint [7] 0 0
Posttreatment Weeks 16 and 20
Secondary outcome [8] 0 0
Percentage of Participants With On-treatment Virologic Failure
Timepoint [8] 0 0
Up to Posttreatment Week 24
Secondary outcome [9] 0 0
Percentage of Participants Experiencing Viral Relapse
Timepoint [9] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
* Chronic genotype 1, 2, 3, or 6 HCV infection
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or nursing female or male with pregnant female partner
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
359
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert H Hyland, DPhil
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT01826981