Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

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

Details

• Lead Sponsor: Humanity & Healthy GI and Liver Centre; Humanity and Health Research Centre
• Collaborators: Beijing 302 Hospital; Nanfang Hospital of Southern Medical University
• Treatments: Interferon-alpha; Interferons; Ledipasvir, sofosbuvir drug combination; Peginterferon alfa-2a; Ribavirin; Simeprevir

Criteria

Inclusion Criteria:

• Individuals with chronic HCV GT1b infection;

• HCV RNA ≥ 10000 IU/mL at screening;

• Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;

• Cirrhosis determination; a liver biopsy may be required;

• Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner;

• HIV or HBV co-infection;

• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;

• Active or recent history (≤ 1 year) of drug or alcohol abuse;

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.