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Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SOF/VEL
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Genotype 1 or 2 HCV infection
  • Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
  • Previously treated with a DAA-containing regimen of at least 4 week duration

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SOF/VEL FDC + RBV 12 weeks

SOF/VEL FDC + RBV 24 weeks

Arm Description

SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection

SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
Change From Baseline in HCV RNA at Week 1
Change From Baseline in HCV RNA at Week 2
Change From Baseline in HCV RNA at Week 3
Change From Baseline in HCV RNA at Week 4
Change From Baseline in HCV RNA at Week 5
Change From Baseline in HCV RNA at Week 6
Change From Baseline in HCV RNA at Week 8
Change From Baseline in HCV RNA at Week 10
Change From Baseline in HCV RNA at Week 12
Change From Baseline in HCV RNA at Week 16
Change From Baseline in HCV RNA at Week 20
Change From Baseline in HCV RNA at Week 24
Percentage of Participants With Overall Virologic Failure
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.

Full Information

First Posted
June 30, 2016
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02822794
Brief Title
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Official Title
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 25, 2016 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL FDC + RBV 12 weeks
Arm Type
Experimental
Arm Description
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
Arm Title
SOF/VEL FDC + RBV 24 weeks
Arm Type
Experimental
Arm Description
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/GS-5816, Epclusa®
Intervention Description
400/100 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
REBETOL®
Intervention Description
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Description
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time Frame
Week 1
Title
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time Frame
Week 2
Title
Percentage of Participants With HCV RNA < LLOQ at Week 3
Time Frame
Week 3
Title
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time Frame
Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at Week 5
Time Frame
Week 5
Title
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time Frame
Week 6
Title
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA < LLOQ at Week 10
Time Frame
Week 10
Title
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time Frame
Week 12
Title
Percentage of Participants With HCV RNA < LLOQ at Week 16
Time Frame
Week 16
Title
Percentage of Participants With HCV RNA < LLOQ at Week 20
Time Frame
Week 20
Title
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time Frame
Week 24
Title
Change From Baseline in HCV RNA at Week 1
Time Frame
Baseline; Week 1
Title
Change From Baseline in HCV RNA at Week 2
Time Frame
Baseline; Week 2
Title
Change From Baseline in HCV RNA at Week 3
Time Frame
Baseline; Week 3
Title
Change From Baseline in HCV RNA at Week 4
Time Frame
Baseline; Week 4
Title
Change From Baseline in HCV RNA at Week 5
Time Frame
Baseline; Week 5
Title
Change From Baseline in HCV RNA at Week 6
Time Frame
Baseline; Week 6
Title
Change From Baseline in HCV RNA at Week 8
Time Frame
Baseline; Week 8
Title
Change From Baseline in HCV RNA at Week 10
Time Frame
Baseline; Week 10
Title
Change From Baseline in HCV RNA at Week 12
Time Frame
Baseline; Week 12
Title
Change From Baseline in HCV RNA at Week 16
Time Frame
Baseline; Week 16
Title
Change From Baseline in HCV RNA at Week 20
Time Frame
Baseline; Week 20
Title
Change From Baseline in HCV RNA at Week 24
Time Frame
Baseline; Week 24
Title
Percentage of Participants With Overall Virologic Failure
Description
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.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Genotype 1 or 2 HCV infection Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy Previously treated with a DAA-containing regimen of at least 4 week duration Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Ehime
Country
Japan
City
Hiroshima
Country
Japan
City
Ichikawa-shi
Country
Japan
City
Iruma-gun
Country
Japan
City
Kashihara
Country
Japan
City
Kurume-shi
Country
Japan
City
Kyoto
Country
Japan
City
Maebashi
Country
Japan
City
Musashino-shi
Country
Japan
City
Nagoya
Country
Japan
City
Nishinomiya
Country
Japan
City
Ogaki City
Country
Japan
City
Okayama
Country
Japan
City
Omura
Country
Japan
City
Sapporo
Country
Japan
City
Suita
Country
Japan
City
Takamatsu-shi
Country
Japan
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.gilead.com/research/disclosure-and-transparency

Learn more about this trial

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

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