NCT03416491

Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C

Evaluation of Efficacy and Safety of KW-136 Plus Sofosbuvir for Treatment-naive Adults Chronically Infected With Hepatitis C Virus: a Randomized, Open-label, Multicenter Phase 2 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Kawin Technology Share-holding Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.

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. KW-136 and sofosbuvir are potent anti-HCV agents targeting at different HCV proteins, namely, nonstructural protein 5A and 5B, respectively. The combination regimen of KW-136 and sofosbuvir is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment. As KW-136 and sofosbuvir are both pan-genotypic anti-HCV agents (in simple words, effective for all known common genotypes of HCV), the combination of these two agents is also supposed to be efficacious for treatment of subjects chronically infected with HCV of all major genotypes and subtypes. An apparent clinical benefit of this pan-genotypic anti-HCV treatment regimen is that no complex, delicate HCV genotype sequencing is required before initiation of treatment to determine genotype-specific treatment alternatives of choice. This advantage is of great significance in the primary care setting.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	KW-136	KW-136 30 mg was provided in 3 capsules, 10 mg each, and KW-136 60 mg in a single capsule of 60 mg.
DRUG	Sofosbuvir	Sofosbuvir was provided in a single tablet of 400 mg.

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-09-17
• Completion: 2017-11-08
• First posted: 2018-01-31
• Last updated: 2018-01-31

Locations

12 sites across 1 country: China