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Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C

NCT03416491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-01-31

No results posted yet for this study

Summary

This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 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

Interventions

DRUG

KW-136

KW-136 30 mg was provided in 3 capsules, 10 mg each, and KW-136 60 mg in a single capsule of 60 mg.

DRUG

Sofosbuvir

Sofosbuvir was provided in a single tablet of 400 mg.

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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-09-17
Completion
2017-11-08

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 NCT03416491 on ClinicalTrials.gov