A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatmentresistant mutations or the durability of sustained virological response (SVR) in patients treated with DAAcontaining regimens for chronic hepatitis C infection (CHC). - ND

Conditions: Chronic Hepatitis C
MedDRA version: 9.1Level: LLTClassification code 10008912

Registration Number: EUCTR2009-016560-36-IT

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 650

Inclusion Criteria

Patients who have participated in Roche DAA treatment protocol(s) for the treatment of CHC infection and have: - Developed DAA-associated resistant mutation(s) which persisted through to the last evaluation of drug resistance in the donor protocol(s); or - Achieved SVR-24, defined as undetectable HCV RNA as measured by the Roche COBAS TaqMan HCV Test (detection limit = 15 IU/mL) = 20 weeks after the last dose of study medication. Et al.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Enrollment in another study for either research or treatment purposes. Patients may provide blood samples for a diagnostic study. 2. Initiation of a treatment after participation in the donor protocol to which there is evidence of cross-resistance to donor protocol DAA.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the ability of DAA-associated resistant mutation(s) to persist following discontinuation of corresponding DAA(s) therapy • To evaluate the durability of SVR attained with DAA-containing regimens.;Secondary Objective: Not applicable;Primary end point(s): There are no formal endpoints for this study. It is considered a long-term monitoring study.

Secondary Outcome Measures