Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
1 other identifier
interventional
102
1 country
33
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.
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 Dec 2016
33 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
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
December 19, 2016
CompletedStudy Start
First participant enrolled
December 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2018
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedFebruary 26, 2019
February 1, 2019
1.1 years
December 15, 2016
February 1, 2019
February 1, 2019
Conditions
Keywords
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 Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes (7)
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 Who Had HCV RNA < LLOQ by Visit While on Treatment
Up to 12 weeks
Change From Baseline in HCV RNA
Baseline and up to 12 weeks
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Baseline to Posttreatment Week 24
- +2 more secondary outcomes
Study Arms (2)
SOF/VEL
EXPERIMENTALSOF/VEL for 12 weeks
SOF/VEL + RBV
EXPERIMENTALSOF/VEL + RBV for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Chronic HCV-infected males and non-pregnant/non-lactating females
- Treatment naive or treatment experienced individuals
- Child-Pugh-Turcotte Score 7-12 at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (33)
Unknown Facility
Shimonoseki, Yamaguchi, Japan
Unknown Facility
Bunkyō City, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Chūō, Japan
Unknown Facility
Ehime, Japan
Unknown Facility
Fukui, Japan
Unknown Facility
Fukuyama-shi, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Ibaraki, Japan
Unknown Facility
Ichikawa, Japan
Unknown Facility
Iizuka, Japan
Unknown Facility
Iruma, Japan
Unknown Facility
Izunokuni, Japan
Unknown Facility
Kashibara, Japan
Unknown Facility
Kofu, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kurume, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Miyazaki, Japan
Unknown Facility
Morioka, Japan
Unknown Facility
Musashino, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nishinomiya, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Ōmura, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Sendai, Japan
Unknown Facility
Shimotsuga-gun, Japan
Unknown Facility
Suita, Japan
Unknown Facility
Takamatsu, Japan
Unknown Facility
Ube, Japan
Unknown Facility
Yamagata, Japan
Related Publications (1)
Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.
RESULT
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
December 15, 2016
First Posted
December 19, 2016
Study Start
December 26, 2016
Primary Completion
February 13, 2018
Study Completion
May 8, 2018
Last Updated
February 26, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-02
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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.