Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Humanity and Health Research Centre

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis C Infection

Treatments

Drug: sofosbuvir and daclatasvir

Drug: ledipasvir/sofosbuvir

Study type

Interventional

Funder types

Other

Identifiers

NCT02576314

H&H_HCV G3 Study

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).