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 |
Infección viral que afecta al hígado. |
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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 | 16.1 |
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 |
1. 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 2. To evaluate the safety and tolerability of MK-5172 in combination with MK-8742 |
1.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. 2. Evaluar la seguridad y la tolerabilidad de MK 5172 en combinación con MK 8742. |
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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 una 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. |
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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 |
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 investigaciones biomédicas futuras consiste en investigar e identificar biomarcadores que proporcionen información a los científicos sobre enfermedades y sus tratamientos. |
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E.3 | Principal inclusion criteria |
1. You are greater than or equal to 18 years of age 2. You have chronic HCV GT1, GT4, GT5, GT6 3. You have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis or no cirrhosis 4. You are treatment naïve to all anti-HCV treatment 5. You are co-infected with HIV-1 |
1.Tener una edad mínima de 18 años el día de la firma del consentimiento informado. 2.Tener una infección crónica documentada por el VHC GT1, GT4, GT5 o GT6 3.Disponer de una evaluación del estadio de la hepatopatía para chequear si presencia o ausencia de cirrosis: Biopsia hepática, Fibroscan o Fibrotest 4.Ausencia de tratamiento previo con todos los tratamientos anti VHC. 5.Presentar una infección por el VIH 1 |
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E.4 | Principal exclusion criteria |
1. You have signs of decompensated liver disease 2. You are coinfected with hepatitis B virus 3. You have signs of hepatocellular carcinoma or history of malignancy 4. You are taking or plan to take any medication not allowed for this study 5. You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus 6. You have exclusionary conditions or lab values 7. You have a history of opportunistic infection 8. You have clinically relevant drug or alcohol abuse within the last 12 months |
1.Presenten indicios de hepatopatía descompensada. 2.Presenten una coinfección por el virus de la hepatitis B 3.Tengan antecedentes de neoplasias malignas o tengan signos de carcinoma hepatocelular. 4.Estén tomando o tengan previsto tomar cualquier tratamiento que no esté permitido en el estudio. 5.Tengan datos o antecedentes de hepatitis crónica no causada por el VHC. 6.Presenten valores analíticos que sean motivo de exclusión 7.Tenga antecedentes de infección oportunista 8.Presenten un consumo excesivo y clínicamente importante de drogas o alcohol en los 12 meses previos a la selección. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The primary efficacy endpoints will be the proportion of subjects achieving SVR12 and 2. To evaluate the safety and tolerability of MK-5172 in combination with MK-8742. |
1. La primera variable de eficacia será la proporción de sujetos que logren una RVS12 2. Evaluar la seguridad y tolerabilidad de MK-5172 en combinación con MK-8742 |
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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 endpoint will be the proportion of subjects achieving SVR24 |
La segunda variable será la proporción de sujetos que logren una RVS24 |
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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 | 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) | 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 | 14 |
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 |
Canada |
Australia |
Israel |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |