NCT04070235

SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C
Nanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 2/3·ClinicalTrials.gov·drug
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
SH229 tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Location
Jilin, China
Timeline & enrollment
Phase
Phase 2/3
Start date
Mar 29, 2019
End date
Aug 01, 2020
Enrollment
440 participants
Primary outcome

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

Summary

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with
 fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with
 chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of
 phase III clinical trials.
 
 Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi
 dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for
 12 weeks, providing a sufficient basis for drug registration and clinical use.

ICD-10 classifications
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04070235
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04070235 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd. and is currently status unknown. The study focuses on Hepatitis C, Chronic. Target enrollment is 440 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.