Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
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|ClinicalTrials.gov Identifier: NCT01910636|
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : March 24, 2015
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Sofosbuvir Drug: RBV||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Sofosbuvir 400 mg tablet administered orally once daily
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)
Other Name: Copegus®
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]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) [ Time Frame: Up to 12 weeks ]The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]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 [ Time Frame: Up to 12 weeks ]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 [ Time Frame: Up to Posttreatment Week 24 ]Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910636
|Study Director:||Steven Knox||Gilead Sciences|