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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019183 |
E.1.2 | Term | HCV |
E.1.2 | System Organ Class | 100000004848 |
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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 effectiveness of MK5172A, a combination tablet of the products MK5172 and MK8742, in clearing the Hepatitis C virus from the blood 12 weeks after completing the study treatment. To evaluate the safety and tolerability of MK5172A, a combination tablet of the products, MK5172 and MK8742.
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E.2.2 | Secondary objectives of the trial |
To evaluate the effectiveness of MK5172A, a combination tablet of the study products MK5172 and MK8742, in clearing the Hepatitis C virus from the blood 24 weeks after completing the study treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible for participation in this trial, the subject must: •Be greater than or equal to 18 years of age. •Test positive for HCV infection (as measured by RNA). •Have chronic genotype 1, 4, 5, or 6 Hepatitis C virus. •Be on opiate substitution therapy (OST), have kept at least 80% of scheduled appointments while on OST, and not missed any scheduled appointments between screening and study entry. •Have had a liver biopsy, Fibroscan, or Fibrotest to check for extent of liver disease and/or cirrhosis or to determine absence of cirrhosis. •Be treatment naïve to all HCV treatment •May be coinfected with HIV1. If positive for HIV-1 co-infection, then subject must be either treatment naïve to any antiretroviral therapy (ART) or have been stable on ART for at least 8 weeks and have no plans to change therapy during the course of the study. ART permitted on the study is a dual NRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirnine). Participants with HIV infection on ART must have a CD4 T-cell count of more than 200 cells/mm3 and have undetectable plasma HIV-1.Participants with HIV infection but naive to ART must have a CD4 T-cell count of more than 500 cells/mm3 and have HIV-RNA levels <50,000 copies/mL. HIV infected participants must not have failed more than 1 past HIV treatment regimen. •Agree to use acceptable methods of contraception. |
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E.4 | Principal exclusion criteria |
The subject must be excluded from participating in the trial if the subject: •Is under the age of legal consent, is mentally ill, is legally incapacitated or has significant emotional or psychiatric problems which may interfere with the study procedures. •Has signs of decompensated liver disease. •Is coinfected with Hepatitis B virus. •Has signs of hepatocellular carcinoma or history of malignancy. •Is taking or plans to take any medication not allowed for this study. •Is currently participating or has participated in a study with an investigational compound within the last 30 days •Is currently using or intends to use barbiturates •Is pregnant or breastfeeding or plans to conceive or donate eggs •Has a history of, or signs of, chronic hepatitis not caused by hepatitis C virus. •Has an exclusionary laboratory value •Has HIV and uses HIV drugs other than a dual NNRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir [or dolutegravir or rilpivine] •Has an organ transplants (other than cornea and hair). •Has poor venous access which may complicate routine peripheral blood sampling •Has history of gastric surgery or malabsorption disorders •Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial. .Has any condition or laboratory abnormality, or history of any illness, which might complicate the results of the study or pose additional risk in administering the study drugs to the subject. •Has a history of opportunistic infection •Is an immediate family member of someone directly involved with this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome of this study is the Sustained Virologic Response rate 12 weeks after the end of all study therapy (SVR12) of the subjects enrolled. This will be defined as HCV RNA levels being less than the lower limits of quantification 12 weeks after the end of all study therapy. The safety and tolerability of MK5172A will also be assessed. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the end of all study therapy |
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E.5.2 | Secondary end point(s) |
The SVR24 rate of subjects enrolled. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 weeks after the end of all study therapy |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 19 |
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 |
Canada |
France |
Germany |
Italy |
Netherlands |
New Zealand |
Norway |
Romania |
Spain |
Taiwan |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 6 |