Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

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

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.

• Phase: Phase 4
• 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. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;

2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;

3. HCV RNA > 10,000 IU/mL at Screening;

4. Screening laboratory values within defined thresholds

5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner;

2. HIV or chronic hepatitis B virus (HBV) infection;

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

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

5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).