Trial | NCT02473211  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    106
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.
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).
Study Started
Jan 31
2015
Primary Completion
Dec 31
2017
Study Completion
Mar 15
2018
Last Update
Mar 19
2018

Drug Sofosbuvir

Sofosbuvir 400 mg tablet administered once daily

  • Other names: GS-7977

Drug Daclatasvir

Daclatasvir 60mg tablet administered once daily

  • Other names: BMS-790052

SOF+DCV Experimental

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Criteria 

Inclusion Criteria:

Patients chronically infected with HCV Genotype-1b;
Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
HCV RNA level greater than 10,000 IU/ml at screening;
Patients with compensated cirrhosis are permitted.

Exclusion Criteria:

Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;
Screening ECG with clinically significant abnormalities;
Laboratory results outside of acceptable ranges at screening;
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
No Results Posted