Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
1 other identifier
interventional
69
4 countries
30
Brief Summary
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2014
30 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
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2016
CompletedResults Posted
Study results publicly available
July 28, 2017
CompletedNovember 16, 2018
June 1, 2017
1.6 years
November 20, 2014
June 30, 2017
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes (4)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ On-treatment
Baseline to Week 24
HCV RNA Change From Baseline
Baseline to Week 24
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (1)
SOF/VEL+RBV
EXPERIMENTALParticipants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA \> LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
You may not qualify if:
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (30)
Unknown Facility
San Diego, California, United States
Unknown Facility
San Marcos, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Wellington, Florida, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Hillsborough, New Jersey, United States
Unknown Facility
Manhasset, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Fayetteville, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Falls Church, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Darlinghurst, New South Wales, Australia
Unknown Facility
Fitzroy, Victoria, Australia
Unknown Facility
Melbourne, Victoria, Australia
Unknown Facility
Murdoch, Western Australia, Australia
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
San Juan, Puerto Rico
Related Publications (1)
Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- 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 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
November 24, 2014
Study Start
December 1, 2014
Primary Completion
July 2, 2016
Study Completion
September 15, 2016
Last Updated
November 16, 2018
Results First Posted
July 28, 2017
Record last verified: 2017-06
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.