An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

• Conditions: Chronic Hepatitis C; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2009-016560-36-AT
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1. Patients who have participated in Roche DAA treatment protocol(s) for the treatment of CHC infection and have:
• Developed DAA-associated resistance mutation(s) which persisted through to the
last evaluation of drug resistance in the donor protocols, or achieved only a partial viral response or experienced viral breakthrough while on mericitabine treatment
(see definitions in Appendix 1) not associated with selection of S282T resistance mutations or any newly identified mericitabine resistance mutation(s),
or
• Achieved SVR-24, as defined by each donor study protocol, measured by the Roche COBAS TaqMan HCV Test = 20 weeks after the last dose of study medication
2. Willingness to give written informed consent and willingness to participate in and
comply with the study requirements
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 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients with any of the following will not be eligible for participation:

1. Patients participating in DAA resistance monitoring: initiation of treatment for
CHC after participation in the donor protocol (except prescribed PEG-IFN/RBV
and/or registered DAAs without evidence of cross-resistance to donor protocol
DAA)
2. Patients participating in DAA SVR durability: treatment with any anti HCV therapy (perceived or known anti-HCV activity) since establishing SVR in the donor study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified