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

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Gilead Sciences

Status and phase

Completed
Phase 3

Conditions

Hepatitis C

Treatments

Drug: Sofosbuvir
Drug: RBV

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910636
GS-US-334-0118

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

153 participants in 1 patient group

Sofosbuvir+RBV 12 weeks
Experimental group
Description:
Participants will receive sofosbuvir+RBV for 12 weeks.
Treatment:
Drug: Sofosbuvir
Drug: RBV

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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