E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To evaluate the ability of DAA-associated resistant mutation(s) to 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 DAAcontaining regimens |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
There are no formal endpoints for this study. It is considered a long-term monitoring study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
There are no formal endpoints for this study. It is considered a long-term monitoring study. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Long-term-follow-up trial, Resistance |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Puerto Rico |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Please refer to the protocol, Section 3.1.1. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |