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 CMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2009-016560-36-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
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
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
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the time DAA-associated resistant mutation(s) persist following discontinuation of corresponding DAA(s) therapy • To collect serum specimens from patients who have exhibited either a partial viral response or viral breakthrough while on mericitabine treatment, that do not present NS5B S282T, the in vitro identified mericitabine-resistant amino acid substitution or any newly identified resistance mutation (see definitions in Appendix 1). The serum specimens will be used to extract viral RNA in order to monitor for resistance mutations that might be identified in the future. • To evaluate the durability of SVR-24, as defined in each donor study protocol, measured by the Roche COBAS TaqMan HCV Test = 20 weeks after the last dose of study medication attained with DAA-containing regimens;Secondary Objective: NA;Primary end point(s): There are no formal endpoints for this study. It is considered a long-term monitoring study. ;Timepoint(s) of evaluation of this end point: NA
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There are no formal endpoints for this study. It is considered a long-term monitoring study.;Timepoint(s) of evaluation of this end point: NA