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 |
A viral infection affecting the liver |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 efficacy of MK-5172A as assessed by the proportion of subjects in the immediate treatment arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy
•To evaluate the safety and tolerability of MK-5172A in the immediate treatment group relative to the placebo treatment of the deferred treatment group.
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E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of MK-5172/MK-8742 as assessed by the proportion of subjects in the immediate treatment arm achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD(u) or TND) 24 weeks after the end of all study therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.≥18 years of age on day of signing informed consent.
2.HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening.
3.documented chronic HCV GT1, GT4 and/or GT6
4.HCV treatment status that is one of the following: HCV Treatment Naïve or HCV Treatment experienced (non DAA treatment)
5.have a diagnosis of Sickle Cell (SS) Disease, β-Thalassemia or Hemophilia A or B or Von Willebrand disease |
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E.4 | Principal exclusion criteria |
1.Coinfection with hepatitis B virus (e.g. HBsAg positive).
2.Prior treatment (defined as 1 dose or more) with direct acting antivirals (DAA) therapy.
3.History of malignancy ≤5 years
4.Evidence of hepatocellular carcinoma (HCC)
5.History of chronic hepatitis not caused by HCV,
6.Exclusionary laboratory values
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E.5 End points |
E.5.1 | Primary end point(s) |
•The primary efficacy endpoint will be the SVR12 rate of the subjects in the immediate treatment arm.
•The primary PK endpoints for MK-5172 and MK-8742 are C2hr and Ctrough. Additional PK parameters such as AUC0-24 may be calculated using population pharmacokinetic modeling approaches.
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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) |
•The secondary efficacy endpoint is the SVR24 rate of the subjects in the immediate treatment arm. |
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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 | 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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Australia |
Austria |
Belgium |
Canada |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Greece |
Hungary |
Israel |
Italy |
Netherlands |
New Zealand |
Poland |
Spain |
Sweden |
United Kingdom |
United States |
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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 | |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |