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Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C

NCT03453346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-03-07

No results posted yet for this study

Summary

This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C Virus Infection, Response to Therapy of

Interventions

DRUG

Sofosbuvir

Generic sofosbuvir tablet 400 mg

DRUG

Ribavirin

Ribavirin was provided in 100-mg tablets.

Sponsors & Collaborators

  • KawinGreen Biotech Co., Ltd.

    collaborator UNKNOWN

  • Kawin Technology Share-holding Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lai Wei, M.D. · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-05
Primary Completion
2017-03-18
Completion
2017-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453346 on ClinicalTrials.gov