SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

• Status: Completed
• Trial end date: 2018-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanity & Healthy GI and Liver Centre; Humanity and Health Research Centre
• Collaborator: Beijing 302 Hospital
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

1. Patients chronically infected with HCV Genotype-1b;

2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;

3. HCV RNA level greater than 10,000 IU/ml at screening;

4. Patients with compensated cirrhosis are permitted.

Exclusion Criteria:

1. 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;

2. Screening ECG with clinically significant abnormalities;

3. Laboratory results outside of acceptable ranges at screening;

4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).