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Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
LDV/SOF
SOF
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:

  • Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
  • Aged 20 years or older
  • Treatment naive or treatment experienced
  • At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

  • Previous exposure to an NS5A or NS5B inhibitor
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing female or male with pregnant female partner

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LDV/SOF (Cohort 1)

SOF+RBV (Cohort 1)

LDV/SOF (Cohort 2)

Arm Description

LDV/SOF FDC for 12 weeks

SOF+RBV for 12 weeks

Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.

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
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
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
April 11, 2016
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02738333
Brief Title
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Official Title
A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
May 11, 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 objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

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
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDV/SOF (Cohort 1)
Arm Type
Experimental
Arm Description
LDV/SOF FDC for 12 weeks
Arm Title
SOF+RBV (Cohort 1)
Arm Type
Experimental
Arm Description
SOF+RBV for 12 weeks
Arm Title
LDV/SOF (Cohort 2)
Arm Type
Experimental
Arm Description
Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®, GS-5885/GS-7977
Intervention Description
90/400 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
400 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 12 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
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
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: Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females Aged 20 years or older Treatment naive or treatment experienced At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV. Key Exclusion Criteria: Previous exposure to an NS5A or NS5B inhibitor Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Pregnant or nursing female or male with pregnant female partner 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
Bunkyo
Country
Japan
City
Chiba
Country
Japan
City
Chuo City
Country
Japan
City
Ehime
Country
Japan
City
Fukuoka
Country
Japan
City
Fukuyama
Country
Japan
City
Gifu
Country
Japan
City
Ibaragi
Country
Japan
City
Ikeda
Country
Japan
City
Iruma-gun
Country
Japan
City
Itabashi
Country
Japan
City
Izunokuni
Country
Japan
City
Kagoshima
Country
Japan
City
Kashihara
Country
Japan
City
Kitakyushu
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Maebashi
Country
Japan
City
Matsumoto
Country
Japan
City
Morioka
Country
Japan
City
Musashino
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Nishinomiya
Country
Japan
City
Ogaki City
Country
Japan
City
Okayama
Country
Japan
City
Omura
Country
Japan
City
Osaka
Country
Japan
City
Sagamihara
Country
Japan
City
Saga
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Suita
Country
Japan
City
Takamatsu
Country
Japan
City
Ube
Country
Japan
City
Yamagata
Country
Japan
City
Yufu
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

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

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