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KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

NCT03995485 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2019-06-25

No results posted yet for this study

Summary

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension treatment-free follow-up period.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

KW-136 capsule

KW-136 60 mg was provided 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

  • Junqi Niu, M.D. · First Hospital of Jilin Univerisity

  • 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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2018-01-25
Completion
2018-03-07

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 NCT03995485 on ClinicalTrials.gov