Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis (ASTRAL-4)

October 19, 2018 updated by: Gilead Sciences

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

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

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Los Angeles, California, United States, 90048
      • Pasadena, California, United States
      • San Francisco, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States, 32256
      • Miami, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
      • Indianapolis, Indiana, United States, 46237
    • Kansas
      • Kansas City, Kansas, United States
    • Louisiana
      • Monroe, Louisiana, United States, 71280
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
      • New York, New York, United States, 10029
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States, 28204
      • Durham, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37211
    • Texas
      • Arlington, Texas, United States, 76012
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Murray, Utah, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, 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 at screening
  • Chronic HCV infection (≥ 6 months)
  • Confirmed CPT class B (7-9) at screening

Exclusion Criteria:

  • Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
  • Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
  • Laboratory results outside of acceptable ranges at screening

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOF/VEL 12 weeks
Participants will receive SOF/VEL FDC for 12 weeks.
Drug: SOF/VEL
400/100 mg tablets administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
EXPERIMENTAL: SOF/VEL+RBV 12 weeks
Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
Drug: SOF/VEL
400/100 mg tablets administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Drug: RBV
Ribavirin (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 24 weeks
Participants will receive SOF/VEL FDC for 24 weeks.
Drug: SOF/VEL
400/100 mg tablets 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) 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
Time Frame: Up to 24 weeks plus 30 days
Up to 24 weeks plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 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 Virologic Failure
Time Frame: Up to Posttreatment Week 24

Virologic failure was defined as

  • On-treatment virologic failure

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)

  • Relapse

    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Up to Posttreatment Week 24
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
Time Frame: Baseline to Posttreatment Week 24
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Baseline to Posttreatment Week 24
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
Time Frame: Baseline to Posttreatment Week 24
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.
Baseline to Posttreatment Week 24

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: Anu M Osinusi, MD, MPH, 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)

August 1, 2015

Study Completion (ACTUAL)

November 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 15, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-1137

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.

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