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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is estimated that China has a population of over 10 million infected with HCV and also a highly variable HCV genotype geographic distribution. A simple, universal, non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical practice and public health. The combination regimen of SH229 and DCV is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	SH229 tablets	SH229 400 mg was provided in 4 tablets, 100mg each；SH229 600 mg was provided in 6 tablets , 100mg each；SH229 800 mg in was provided in 8tablets , 100mg each。
DRUG	Daclatasvir dihydrochloride	Daclatasvir dihydrochloride was provided in a single tablet of 60 mg.

Timeline

• Start date: 2019-03-29
• Primary completion: 2019-12-01
• Completion: 2020-08-01
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

1 site across 1 country: China