Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 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 genotype 3 infection.

• Phase: 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: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

• Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;

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

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

• Screening laboratory values within defined thresholds;

• Negative pregnancy test at baseline (females of childbearing potential only);

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

Exclusion Criteria:

• Pregnant or nursing female;

• HIV infection or HBV infection (HBcAb and HBsAg positive);

• 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).