Back to resultsEfficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Sofosbuvir
RBV
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring HCV genotype 2 (GT-2)
Eligibility Criteria
Inclusion Criteria:
- Chronic genotype 2 HCV-infection
- Male or female, age ≥ 20 years
- Body weight ≥ 40 kg
- HCV RNA ≥ 10,000 IU/mL at screening
Exclusion Criteria:
- Current or prior history of clinically significant illness other than HCV
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sofosbuvir+RBV 12 weeks
Arm Description
Participants will receive sofosbuvir+RBV for 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910636
Brief Title
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Official Title
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese 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
Keywords
HCV genotype 2 (GT-2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sofosbuvir+RBV 12 weeks
Arm Type
Experimental
Arm Description
Participants will receive sofosbuvir+RBV for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®
Intervention Description
Sofosbuvir 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Copegus®
Intervention Description
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 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) at 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Description
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants Experiencing Viral Breakthrough
Description
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.
Time Frame
Up to 12 weeks
Title
Percentage of Participants Experiencing Viral Relapse
Description
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Time Frame
Up to Posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic genotype 2 HCV-infection
Male or female, age ≥ 20 years
Body weight ≥ 40 kg
HCV RNA ≥ 10,000 IU/mL at screening
Exclusion Criteria:
Current or prior history of clinically significant illness other than HCV
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non-HCV etiology
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Knox
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Akita
Country
Japan
City
Chiba
Country
Japan
City
Chiyoda-ku
Country
Japan
City
Gifu
Country
Japan
City
Ichikawa
Country
Japan
City
Itabashi-ku
Country
Japan
City
Izunokuni
Country
Japan
City
Kita-Ku
Country
Japan
City
Kurashiki
Country
Japan
City
Kurume
Country
Japan
City
Matsumoto
Country
Japan
City
Musashino
Country
Japan
City
Nishinomiya
Country
Japan
City
Ogaki
Country
Japan
City
Omura
Country
Japan
City
Sapporo
Country
Japan
City
Shinjuku-ku
Country
Japan
City
Suita
Country
Japan
City
Yamagata
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
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