Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (ASTRAL-3)

October 19, 2018 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

558

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
    • Queensland
      • Brisbane, Queensland, Australia, 4064
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Fitzroy, Melbourne, Victoria, Australia, 3065
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Fremantle, Western Australia, Australia, 6010
      • Perth, Western Australia, Australia, 6000
  • Canada
      • Toronto, Canada, M5T 2S8
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z 2C7
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
  • France
      • Clermont-Ferrand, France, 63000
      • Clichy, France, 92110
      • Creteil, France, 94000
      • Lille, France, 59037
      • Limoges, France, 87042
      • Lyon, France, 69004
      • Marseille, France, 13008
      • Paris, France, 75014
      • Pessac, France
      • Toulouse, France, 31059
      • Villejuif, France, 94804
  • Germany
      • Berlin, Germany, 12157
      • Berlin, Germany, D-10969
      • Hamburg, Germany
      • Hannover, Germany, 30625
      • München, Germany, 81377
    • Hessin
      • Frankfurt am Main, Hessin, Germany, 60590
    • NRW
      • Hufelandstr, NRW, Germany, 45122
      • Koln, NRW, Germany, 50932
    • North Rhine-Westphalia
      • Duesseldorf, North Rhine-Westphalia, Germany, 40237
  • Italy
      • Firenze, Italy, 50012
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand, 8011
  • Puerto Rico
      • San Juan, Puerto Rico
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, W2 1NY
      • London, United Kingdom, NW3 2PF
      • London, United Kingdom, E1 4AT
      • London, United Kingdom, SW170QT
      • Manchester, United Kingdom, M8 5RB
      • Nottingham, United Kingdom, NG7 2UH
      • Oxford, United Kingdom, OX3 9DU
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
  • United States
    • California
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90048
      • Sacramento, California, United States
      • San Diego, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maryland
      • Lutherville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL
  • HCV genotype 3
  • Chronic HCV infection (≥ 6 months)
  • Females of childbearing potential must have a negative serum pregnancy test
  • 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) that may interfere with subject treatment, assessment or compliance with the protocol
  • Screening ECG with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at Screening
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: SOF/VEL 12 Weeks
SOF/VEL FDC for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
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
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 24

Virologic failure was defined as:

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Time Frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.
Posttreatment Weeks 4 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: John McNally, PhD, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-1140
  • 2014-001682-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C Virus Infection

Clinical Trials on SOF/VEL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe