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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016560-36-DE

Enrollment

650

Registered

2010-06-18

Start date

2010-07-27

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: RO5024048/F06 Pharmaceutical Form: Film-coated tablet Current Sponsor code: RO5024048 Other descriptive name: HCV Polymerase Inhibitor Prodrug Trade Name: Pegasys Pharmaceutical Form: S

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria, Canada, France, Germany, Italy, Poland, Puerto Rico, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line (TIS

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026