E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Virus Infection (HCV) |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Virus Infection |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | 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 durability of SVR in subjects who remained HCV RNA <25 IU/mL throughout the follow-up period of the treatment protocol and did not start any new HCV therapy between the end of the previous protocol and entry in this study. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the presence of antiviral resistance to MK-5172 and determine if there is a reversion to a wild-type pattern within the 3 or 5 year timeframe if subjects were from PN 052 or PN 059) of this long-term follow-up study.
2. To evaluate the long term safety of MK-5172
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.” |
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E.3 | Principal inclusion criteria |
1. HCV infected subjects who previously participated in an MK-5172 protocol that includes
MK-5172 in the treatment regimen.
2. Subject must enroll (Visit 1) within three months of the last study visit (e.g. follow-up
week 24) of their previous protocol in which they received an MK-5172 containing
regimen.
Prior to Amendment 03, if a patient in a treatment protocol received extended followup
(≥1 year) in the original protocol, they may enroll in this study at the final visit of
the previous protocol.
3. Subject must be ≥ 18 years of age and willing to give written informed consent.
4. Subjects, who have consented for the trial, may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
5. For Amendment 03: Subjects must have received a MK-5172 containing regimen in a
prior trial and have been identified as having failed therapy in that study. |
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E.4 | Principal exclusion criteria |
1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded.
2. The subject has received HCV therapy after completion of the protocol defined MK-
5172 treatment trial regimen and before or after entry into PN 017.
3. For Amendment 03: Subjects who fail therapy due to re-infection are excluded.
4. For Amendment 03: Subjects who fail therapy and receive retreatment with HCV
therapy are excluded, except in the case where they were re-treated in a Mercksponsored
protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A primary efficacy endpoint is the durability of long-term SVR which will be evaluated based upon the time to viral relapse. Viral relapse is defined as any subject who has confirmed HCV RNA > or = LLoQ and was previously <LLoQ at end of treatment and TND or TD(u) during the follow-up period of the previous trial. Relapse would be indicated so long as this was the same genotype of the virus seen in the parent protocol (eg. not a new infection or re-infection (see Section 2.5). Time to relapse is defined as the time from last dose of study therapy taken in previous trial until the date where HCV RNA is > or = LLoQ . The percentage of subjects who remain HCV RNA <LLoQ during the course of this study will also be estimated.
In subjects with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis will be performed to evaluate the presence of RAVs and the persistence of RAVs over time
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Durability of SVR (Time to viral relapse) for all subjects entered whose HCV RNA was TND at the end of treatment and TND or TD(u) throughout the followup period of the previous protocol and who did not start new HCV treatment between end of previous protocol and study entry.
Antiviral resistance for all subjects with HCV RNA ≥1000 IU/mL at study entry or during the study
To evaluate the presence of antiviral resistance to MK-5172 and determine if there is a reversion to a wild-type pattern within the 3 or 5 year time-frame if subjects were from PN 052 or PN 059 of this long-term follow-up study.
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E.5.2 | Secondary end point(s) |
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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 | Yes |
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 | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Long term follow-up study; no therapy is being provided. |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 109 |
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 |
Argentina |
Australia |
Belgium |
Canada |
Denmark |
France |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
New Zealand |
Puerto Rico |
Spain |
Sweden |
Turkey |
United Kingdom |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 16 |