Overview

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.
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
Emory University
Treatments:
Asunaprevir
Sofosbuvir
Criteria
Inclusion Criteria:

- Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;

- HCV RNA level > 10,000 and < 10,000,000 IU/ml at Screening;

- Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at
Day 2;

- No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months
of study entry:

1. Liver biopsy showing cirrhosis;

2. Fibroscan showing cirrhosis or results>12.5 kPa ;

3. FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio
index (APRI) >2 during screening.

Exclusion Criteria:

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

- HIV or chronic hepatitis B virus (HBV) infection;

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

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

- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin
cancers);

- 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.