E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long-term Follow-up of prior study participants |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019641 |
E.1.2 | Term | Hepatic cirrhosis |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
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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 |
This study will be conducted in two parts as described below: Part 1: Part 1 will include subjects who participated in a Phase 1, 2, or 3 clinical study in which boceprevir was administered. Part 2: Part 2 will include subjects who participated in a Phase 1, 2, or 3 clinical study in which narlaprevir was administered. Parts 1 and 2 have three primary objectives: -Confirm the durability of the virologic response in subjects with chronic hepatitis C who were sustained responders 24 weeks post-treatment in the previous study. -Characterize the long-term safety in subjects who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. -Characterize the natural history of HCV sequence variants in subjects who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study.
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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 |
-Subject must be willing to give written informed consent. -Subject must have received at least one dose of any study medication (peginterferon, ribavirin, boceprevir or narlaprevir) in a previous SPRI Phase 1, 2, or 3 clinical study in which boceprevir or narlaprevir was administered.
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E.4 | Principal exclusion criteria |
-Concurrent participation in any other clinical study for the treatment of chronic hepatitis C. -Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the SPRI Phase 1, 2, or 3 clinical study in which the subject previously participated. -Any condition which in the opinion of the Investigator would make the subject unsuitable for enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint in this study is the durability of virologic response in subjects with chronic hepatitis C who were sustained responders at 24 weeks posttreatment in the previous study. A subject is classified as a sustained responder at a given time point if HCV-RNA is below the lower limit of detection at that time point. In addition, the study will also characterize the following: -The long-term safety in subjects who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. -The natural history of HCV sequence variants in subjects who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study.
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Assess durability of response and characterize the natural history of HCV sequence varients |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |