NCT02473211

SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Humanity and Health Research Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Detailed description

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg tablet administered once daily
DRUG	Daclatasvir	Daclatasvir 60mg tablet administered once daily

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-31
• Completion: 2018-03-15
• First posted: 2015-06-16
• Last updated: 2018-03-19

Locations

2 sites across 1 country: China