Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection
2 other identifiers
interventional
111
9 countries
61
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
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 Feb 2015
Shorter than P25 for phase_3
61 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
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedStudy Start
First participant enrolled
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2016
CompletedResults Posted
Study results publicly available
May 3, 2017
CompletedNovember 16, 2018
March 1, 2017
1.1 years
January 21, 2015
March 23, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was 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 12 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 While on Treatment
Baseline to Week 12
HCV RNA Change From Baseline
Baseline to Week 12
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (1)
SOF/VEL
EXPERIMENTALSOF/VEL for 12 weeks
Interventions
400/100 mg tablet administered orally once daily
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
- HCV RNA ≥ 10\^4 IU/mL at screening
- Classification as treatment naive or treatment experienced
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
You may not qualify if:
- Current or prior history of 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 electrocardiogram (ECG) with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (61)
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Diego, California, 92154, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Gainesville, Florida, 32610-0272, United States
Unknown Facility
Jacksonville, Florida, 32256, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Marietta, Georgia, 30066, United States
Unknown Facility
Indianapolis, Indiana, 46237, United States
Unknown Facility
Baltimore, Maryland, 21202, United States
Unknown Facility
Boston, Massachusetts, 02129, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15240, United States
Unknown Facility
Providence, Rhode Island, 02905, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Nashville, Tennessee, 37211, United States
Unknown Facility
Richmond, Virginia, 23226, United States
Unknown Facility
Antwerp, 2060, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Vancouver, British Columbia, V6Z2C7, Canada
Unknown Facility
Montreal, Quebec, H2X 0A9, Canada
Unknown Facility
Toronto, M5T 2S8, Canada
Unknown Facility
Clermont-Ferrand, 63000, France
Unknown Facility
Clichy, 92110, France
Unknown Facility
Créteil, 94000, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lyon, 69004, France
Unknown Facility
Marseille, 13008, France
Unknown Facility
Paris, 75014, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Villejuif, 94804, France
Unknown Facility
Cologne, North Rhine-Westphalia, 50932, Germany
Unknown Facility
Düsseldorf, North Rhine-Westphalia, 40237, Germany
Unknown Facility
Berlin, D-10969, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
München, 81377, Germany
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
San Giovanni Rotondo, Foggia, 71013, Italy
Unknown Facility
Florence, 50012, Italy
Unknown Facility
San Juan, 09027, Puerto Rico
Unknown Facility
Plymouth, Devon, PL6 8DH, United Kingdom
Unknown Facility
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
Unknown Facility
London, E1 4AT, United Kingdom
Unknown Facility
London, NW3 2PF, United Kingdom
Unknown Facility
London, W2 1NY, United Kingdom
Unknown Facility
Manchester, M8 5RB, United Kingdom
Unknown Facility
Oxford, OX3 9DU, United Kingdom
Related Publications (2)
Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8.
BACKGROUNDAsselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4.
PMID: 31216086DERIVED
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 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
January 27, 2015
Study Start
February 23, 2015
Primary Completion
March 23, 2016
Study Completion
June 15, 2016
Last Updated
November 16, 2018
Results First Posted
May 3, 2017
Record last verified: 2017-03
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.