Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
ASTRAL-1
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
2 other identifiers
interventional
741
9 countries
80
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2014
Shorter than P25 for phase_3
80 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
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
September 16, 2016
CompletedNovember 15, 2018
July 1, 2016
11 months
July 24, 2014
July 27, 2016
October 19, 2018
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 Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes (4)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (2)
SOF/VEL
EXPERIMENTALSOF/VEL for 12 weeks
Placebo
PLACEBO COMPARATORSOF/VEL placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10\^4 IU/mL at screening
- HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- 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 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 (80)
Unknown Facility
Little Rock, Arkansas, United States
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Long Beach, California, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90036, United States
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Los Angeles, California, 90048, United States
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Palo Alto, California, United States
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Sacramento, California, United States
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San Diego, California, 92123, United States
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San Diego, California, 92154, United States
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Aurora, Colorado, 80045, United States
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Gainesville, Florida, 32610-0272, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, 30308, United States
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Marietta, Georgia, United States
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Chicago, Illinois, 60611, United States
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Indianapolis, Indiana, 46237, United States
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Baltimore, Maryland, United States
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Lutherville, Maryland, 21093, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48188, United States
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New York, New York, 10021, United States
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The Bronx, New York, 10468, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15240, United States
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Providence, Rhode Island, 02905, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, 78215, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Antwerp, 2060, Belgium
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Brussels, 1070, Belgium
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Kortrijk, 8500, Belgium
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z2C7, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Toronto, M5T 2S8, Canada
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Hong Kong, China
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Clermont-Ferrand, 63000, France
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Clichy, 92110, France
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Créteil, 94000, France
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Lille, 59037, France
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Limoges, 87042, France
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Lyon, 69004, France
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Marseille, 13008, France
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Paris, 75014, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Villejuif, 94804, France
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Frankfurt am Main, Hessin, 60590, Germany
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Cologne, North Rhine-Westphalia, 50932, Germany
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Düsseldorf, North Rhine-Westphalia, 40237, Germany
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Hufelandstr, North Rhine-Westphalia, 45122, Germany
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Berlin, 12157, Germany
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Berlin, D-10969, Germany
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Hamburg, 20099, Germany
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Hanover, 30625, Germany
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München, 81377, Germany
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San Giovanni Rotondo, Foggia, 71013, Italy
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San Giovanni Rotondo, Foggia, Italy
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Florence, 50012, Italy
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San Juan, Puerto Rico
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Plymouth, Devon, PL6 8DH, United Kingdom
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Portsmouth, Hampshire, PO6 3LY, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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London, E1 4AT, United Kingdom
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London, NW3 2PF, United Kingdom
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London, SE5 9RS, United Kingdom
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London, SW170QT, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
Unknown Facility
Oxford, OX3 9DU, United Kingdom
Related Publications (5)
Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.
RESULTFeld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.
PMID: 26571066RESULTFeld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A.
RESULTJacobson IM, Bourgeois S, Mathurin P, Thuluvath P, Ryder SD, Gerken G, Hernandez C, Vanstraelen K, Scherbakovsky S, Osinusi A, Tedesco D, Foster GR. The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis. J Viral Hepat. 2023 May;30(5):448-454. doi: 10.1111/jvh.13814. Epub 2023 Mar 2.
PMID: 36740893DERIVEDYounossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.
PMID: 27847279DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
John McNally, PhD
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2014
First Posted
July 28, 2014
Study Start
July 1, 2014
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
November 15, 2018
Results First Posted
September 16, 2016
Record last verified: 2016-07
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.