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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02202980




Registration number
NCT02202980
Ethics application status
Date submitted
25/07/2014
Date registered
29/07/2014

Titles & IDs
Public title
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Scientific title
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Secondary ID [1] 0 0
GS-US-337-1468
Universal Trial Number (UTN)
Trial acronym
LEPTON
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 - RBV
Treatment: Drugs - SOF/VEL
Treatment: Drugs - VOX

Experimental: LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) - Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for = 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.

Experimental: LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2) - Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for = 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.

Experimental: LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) - Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.

Experimental: LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) - Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.

Experimental: LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) - Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.

Experimental: LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2) - Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.

Experimental: SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) - Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.

Experimental: SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) - Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.

Experimental: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) - Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) - Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) - Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) - Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) - Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) - Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.

Experimental: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) - Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.


Treatment: Drugs: LDV/SOF
90/400 mg FDC tablet administered orally once daily

Treatment: Drugs: RBV
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: SOF/VEL
400/100 mg FDC tablet administered orally once daily

Treatment: Drugs: VOX
100 mg tablet administered orally once daily with food
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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Timepoint [1] 0 0
Posttreatment Weeks 4 and 24
Secondary outcome [2] 0 0
Percentage of Participants With Virologic Failure
Timepoint [2] 0 0
Up to Posttreatment Week 24
Secondary outcome [3] 0 0
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Timepoint [3] 0 0
Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Eligibility
Key inclusion criteria
Key

* Willing and able to provide written informed consent
* Chronic HCV infection
* Cirrhosis determination (liver biopsy may be required)
* Screening laboratory values within specified limits
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Pregnant or nursing female, or male with pregnant female partner
* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
* Use of any prohibited concomitant medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
4/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2016
Sample size
Target
Accrual to date
Final
273
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
Gilead Study Director
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/NCT02202980