E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019751 |
E.1.2 | Term | Hepatitis C virus |
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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 |
In patients who have persistent HCV infection after prior participation in a MK-7009 clinical trial: Evaluate the safety and tolerability of MK-7009 600 mg b.i.d. for 48 weeks when used in combination with peg-IFN alfa-2a and RBV. |
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E.2.2 | Secondary objectives of the trial |
In patients previously treated with placebo + peg-IFN + RBV in a MK-7009 clinical trial, evaluate the antiviral activity of MK-7009 600 mg b.i.d., defined as Sustained Viral Response (SVR24) as measured by undetectable HCV viral RNA at 24 weeks after completion of treatment with MK-7009 600 mg b.i.d., peg-IFN alfa-2a and RBV. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient has either completed or discontinued participation in an eligible MK-7009 parent protocol, and the SPONSOR has provided written confirmation to the study site that the patient may be offered participation in PN028.
Patient has had an eye examination prior to the start of study therapy per the peg-IFN alfa-2a product label
Female patient who is of childbearing potential or male patient with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control throughout treatment, and after completing all treatment, in accordance with the local peg-IFN alfa-2a and RBV product labels
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E.4 | Principal exclusion criteria |
Patient received investigational therapy for HCV infection between the time of completion or discontinuation of the parent study and initiation of treatment in PN028. Patient discontinued MK-7009 and/or peg-IFN and/or RBV in the parent protocol due to a safety or tolerability issue In the opinion of the investigator, the patient is unlikely to tolerate 48 weeks of continuous therapy with MK-7009 600 mg b.i.d., peg-IFN alfa-2a and RBV. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering MK-7009, peg-IFN alfa-2a and/or RBV to the patient.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter will be the proportion of patients achieving SVR24 (undetectable viral RNA 24 weeks after end of treatment), in patients previously treated with placebo + peg-IFN + RBV in a MK-7009 clinical trial. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | 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) | 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 | Yes |
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 |
roll-over from MK-7009 parent protocols |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 | 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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Completion of all visits through Week 72 for patients achieving SVR and completion of all visits through Week 104 for virologic failures |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 0 |