Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
1 other identifier
interventional
117
1 country
18
Brief Summary
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedStudy Start
First participant enrolled
July 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2017
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedNovember 14, 2018
July 1, 2018
10 months
June 30, 2016
May 24, 2018
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes (27)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Week 1
Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3
Week 3
- +22 more secondary outcomes
Study Arms (2)
SOF/VEL FDC + RBV 12 weeks
EXPERIMENTALSOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL FDC + RBV 24 weeks
EXPERIMENTALSOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Interventions
400/100 mg tablet administered orally once daily
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Eligibility Criteria
You may qualify if:
- Genotype 1 or 2 HCV infection
- Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
- Previously treated with a DAA-containing regimen of at least 4 week duration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (18)
Unknown Facility
Ehime, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Ichikawa-shi, Japan
Unknown Facility
Iruma-gun, Japan
Unknown Facility
Kashihara, Japan
Unknown Facility
Kurume-shi, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Maebashi, Japan
Unknown Facility
Musashino-shi, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nishinomiya, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Ōgaki, Japan
Unknown Facility
Ōmura, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Suita, Japan
Unknown Facility
Takamatsu, Japan
Unknown Facility
Yamagata, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 4, 2016
Study Start
July 25, 2016
Primary Completion
June 2, 2017
Study Completion
August 25, 2017
Last Updated
November 14, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.