Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

March 23, 2022 updated by: Gilead Sciences

A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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

  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Fukuoka-shi, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital
      • Hiroshima-shi, Japan, 734-8551
        • Hiroshima University Hospital Institution Review Board
      • Iizuka, Japan, 820-8505
        • Iizuka Hospital
      • Inzai-shi, Japan, 2701694
        • Nippon Medical School Hospital
      • Iruma, Japan, 350-0495
        • Saitama Medical University Hospital
      • Izunokuni, Japan, 410-2295
        • Juntendo University Shizuoka Hospital
      • Kashihara-shi, Japan, 634-8522
        • Nara Medical University Hospital
      • Kawasaki-shi, Japan, 213-8587
        • Toranomon Hospital Kajigaya
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General hospital
      • Kurume-shi, Japan, 830-0011
        • Kurme University Hospital
      • Matsuyama-shi, Japan, 7908524
        • Matsuyama Red Cross Hospital
      • Musashino, Japan, 180-8610
        • Japanese Red Cross Musashino Hospital
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine Hospital Institutional Review Board
      • Omura-shi, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center
      • Osaka, Japan, 543-8555
        • Osaka Red Cross Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Sapporo-shi, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
      • Takamatsu-shi, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital

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

Key Inclusion Criteria:

  • Chronic HCV-infected males and non-pregnant/non-lactating females
  • Treatment-naïve or treatment-experienced individuals
  • Compensated cirrhosis at Screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOF/VEL
Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.
Drug: SOF/VEL
Tablets administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
Time Frame: First dose date up to Week 12.1
TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.
First dose date up to Week 12.1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
Time Frame: Posttreatment Week 4
SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.
Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
Time Frame: Posttreatment Week 24
SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.
Posttreatment Week 24
Percentage of Participants With Virologic Failure
Time Frame: First dose date 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 IL/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 end of treatment.
First dose date up to posttreatment Week 24

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

October 16, 2019

Primary Completion (ACTUAL)

March 26, 2021

Study Completion (ACTUAL)

June 25, 2021

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (ACTUAL)

October 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-5531
  • JapicCTI-194989 (REGISTRY: Japan Pharmaceutical Information Center)

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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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