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Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

NCT ID: NCT02346721

Last Updated: 2018-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-23

Study Completion Date

2016-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF/VEL

SOF/VEL for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg tablet administered orally once daily

Interventions

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SOF/VEL

400/100 mg tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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GS-7977/GS-5816 Epclusa®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Palo Alto, California, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Gainesville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Wellington, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Marietta, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Providence, Rhode Island, United States

Site Status

Germantown, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Richmond, Virginia, United States

Site Status

Antwerp, , Belgium

Site Status

Brussels, , Belgium

Site Status

Edmonton, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Toronto, , Canada

Site Status

Clermont-Ferrand, , France

Site Status

Clichy, , France

Site Status

Créteil, , France

Site Status

Lille, , France

Site Status

Limoges, , France

Site Status

Lyon, , France

Site Status

Marseille, , France

Site Status

Paris, , France

Site Status

Pessac, , France

Site Status

Toulouse, , France

Site Status

Villejuif, , France

Site Status

Cologne, North Rhine-Westphalia, Germany

Site Status

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Berlin, , Germany

Site Status

Hamburg, , Germany

Site Status

Hanover, , Germany

Site Status

München, , Germany

Site Status

Hong Kong, , Hong Kong

Site Status

San Giovanni Rotondo, Foggia, Italy

Site Status

Florence, , Italy

Site Status

San Juan, , Puerto Rico

Site Status

Plymouth, Devon, United Kingdom

Site Status

Portsmouth, Hampshire, United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Oxford, , United Kingdom

Site Status

Countries

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United States Belgium Canada France Germany Hong Kong Italy Puerto Rico United Kingdom

References

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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.

Reference Type BACKGROUND

Asselah 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.

Reference Type DERIVED
PMID: 31216086 (View on PubMed)

Other Identifiers

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2014-003898-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-342-1446

Identifier Type: -

Identifier Source: org_study_id

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