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KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C - Trial NCT03995485

Access comprehensive clinical trial information for NCT03995485 through Pure Global AI's free database. This Phase 3 trial is sponsored by Kawin Technology Share-holding Co., Ltd. and is currently Completed. The study focuses on Hepatitis C, Chronic. Target enrollment is 371 participants.

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NCT03995485
Phase 3
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03995485
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KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C
Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study

Study Focus

Hepatitis C, Chronic

KW-136 capsule

Interventional

drug

Sponsor & Location

Kawin Technology Share-holding Co., Ltd.

Beijing,Beijing,Beijing,Beijing,Chongqing,Wanzhou,Guangzhou,Guanzhou,Liuzhou,Zhengzhou,Wuhan,Nanjing,Changchun,Yanbian,Shenyang,Xi'an,Ji'nan,Chengdu,รœrรผmqi, China

Timeline & Enrollment

Phase 3

Jun 07, 2017

Mar 07, 2018

371 participants

Primary Outcome

Sustained virologic response at 12 weeks after end of treatment (SVR12)

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.

ICD-10 Classifications

Chronic viral hepatitis C
Acute hepatitis C
Chronic hepatitis, unspecified
Chronic viral hepatitis
Chronic viral hepatitis, unspecified

Data Source

ClinicalTrials.gov

NCT03995485

Non-Device Trial