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SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C - Trial NCT04070235

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.

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NCT04070235
Phase 2/3
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04070235
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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

Study Focus

Hepatitis C, Chronic

SH229 tablets

Interventional

drug

Sponsor & Location

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Jilin, China

Timeline & Enrollment

Phase 2/3

Mar 29, 2019

Aug 01, 2020

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

Data Source

ClinicalTrials.gov

NCT04070235

Non-Device Trial