Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910636
• Other study ID #: GS-US-334-0118
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2013
• Last updated: March 13, 2015
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• RBV
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment Week 12	No
Primary	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.	Up to 12 weeks	No
Secondary	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.	Posttreatment Weeks 4 and 24	No
Secondary	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.	Up to 12 weeks	No
Secondary	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.	Up to Posttreatment Week 24	No