E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
A viral infection affecting the liver |
Infección viral que afecta al hígado. |
|
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-5172 in combination with MK-8742 as assessed by the proportion of subjects 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-5172 in combination with MK-8742. |
-Evaluar la eficacia de MK 5172 en combinación con MK 8742 mediante la proporción de sujetos que logren una RVS12 (respuesta virológica sostenida 12 semanas después del final de todo el tratamiento del estudio), definida como una concentración de ARN del VHC <LIC (objetivo detectable no cuantificable [OD(nc)] u objetivo no detectable [OND]) 12 semanas después del final de todo el tratamiento del estudio.
-Evaluar la seguridad y la tolerabilidad de MK 5172 en combinación con MK 8742. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects 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. |
Evaluar la eficacia de MK 5172 en combinación con MK 8742 mediante la proporción de sujetos que logren: RVS24 (respuesta virológica sostenida 24 semanas después del final de todo el tratamiento del estudio), definida como una concentración de ARN del VHC <LIC (OD(nc) u OND) 24 semanas después del final de todo el tratamiento del estudio. |
|
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 |
The Sponsor will conduct Future Biomedical Research on specimens routinely and specifically collected during this clinical trial. This research may include genetic analyses (DNA), and/or the measurement of other analytes.
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. |
El promotor llevará a cabo investigaciones biomédicas futuras con las muestras obtenidas de forma sistemática y específica durante este estudio clínico. Esta investigación podría incluir análisis genéticos (ADN) o la determinación de otras variables. Estas investigaciones tendrán por objeto el análisis de biomarcadores para abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del estudio principal) y solo se llevarán a cabo en muestras de los sujetos que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para investigación biomédica futura consiste en investigar e identificar biomarcadores que proporcionen información a los científicos sobre
enfermedades y sus tratamientos |
|
E.3 | Principal inclusion criteria |
-You are greater than or equal to 18 years of age.
-You have chronic genotype 1, 4, 5, or 6 Hepatitis C virus.
-You must 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
-You have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis or no cirrhosis.
-You are treatment naïve to all HCV treatment
-You may be co-infected with HIV |
-Tener una edad mínima de 18 años
-Tener una infección crónica documentada por el VHC GT1, 4, 5 o 6.
-Haber recibido tratamiento de sustitución de opiáceos (TSO), haber acudido sistemáticamente como mínimo al 80 % de las visitas programadas durante el TSO y no haber faltado a ninguna visita programada entre la selección y la entrada en el estudio.
-Disponer biopsia hepática, Fibroscan o Fibrotest para chequear si hay o no cirrosis.
-No haber recibido ningún tratamiento para el VHC
-Pueden presentar una infección por el VIH 1 |
|
E.4 | Principal exclusion criteria |
-You have signs of decompensated liver disease.
-You are coinfected with Hepatitis B virus.
-You have signs of hepatocellular carcinoma or history of malignancy.
-You are taking or plan to take any medication not allowed for this study.
-You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus.
-You have an exclusionary laboratory value
-If you have HIV, you use HIV drugs other than a dual NNRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir [or dolutegravir or rilpivine]
-You have a history of opportunistic infection in the preceding 6 months prior to screening. |
-Presenten indicios de hepatopatía descompensada
-Presenten una infección simultánea por el virus de la hepatitis B.
-Tengan antecedentes de neoplasias malignas o signos de carcinoma hepatocelular.
-Estén recibiendo o tengan previsto recibir cualquiera de los medicamentos prohibidos en el estudio
-Tengan signos actuales o antecedentes de hepatitis crónica no causada por el VHC
-Presenten valores analíticos que sean motivo de exclusión
-Si el sujeto está infectado por el VIH, uso de fármacos contra el VIH distintos de un régimen de base con dos ITIN de tenofovir o abacavir y emtricitabina o lamivudina MÁS raltegravir [o dolutegravir o rilpivirina].
-Tengan antecedentes de infección oportunista en los 6 meses anteriores a la selección |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The SVR12 rate of subjects enrolled. |
Proporción de sujetos que logren una RVS12 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The SVR24 rate of subjects enrolled. |
Proporción de sujetos que logren una RVS24 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | 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 |
Belgium |
Canada |
France |
Germany |
Greece |
Ireland |
Israel |
Italy |
Lithuania |
Malaysia |
Netherlands |
New Zealand |
Norway |
Romania |
Spain |
Taiwan |
United Kingdom |
United States |
|
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
|
|
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 | 17 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 17 |
E.8.9.2 | In all countries concerned by the trial days | 0 |