E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic hepatitis C virus infection |
Infección cronica por el virus de la Hepatitis C |
|
E.1.1.1 | Medical condition in easily understood language |
chronic hepatitis C virus infection |
Infección cronica por el virus de la Hepatitis C |
|
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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 assess the hepatitis C antiviral efficacy of telaprevir, peginterferon alfa-2a, and ribavirin |
Evaluar la eficacia antivírica en la Hepatitis C de telaprevir, peginterferon alfa-2a y reibavirina |
|
E.2.2 | Secondary objectives of the trial |
- To assess safety and tolerability of telaprevir, peginterferon alfa-2a, and ribavirin - To evaluate the pharmacokinetics of telaprevir, peginterferon alfa-2a, and ribavirin, and select highly active antiretroviral therapies - To monitor amino acid sequence changes in the HCV NS3.4A protease region |
- Evaluar la seguridad y tolerabilidad de telaprevir, peginterferón alfa-2a y ribavirina. - Evaluar la famacocinética de telaprevir, peginterferón alfa-2a, ribavirina y fármacos del TARGA seleccionado. - Controlar los cambios en la secuencia de aminoácidos en la región de la proteasa NS3.4A del VHC. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects must have chronic, genotype 1a or 1b, hepatitis C at Screening - Subjects must have a diagnosis of HIV-1 infection >6 months before Screening - Taking 1 of the following permissible HAART regimens for HIV continuously >/=12 weeks before Day 1 without switches - Male and female subjects 18 to 65 years of age, inclusive - Female subjects must not be pregnant or planning to become pregnant within 72 weeks after enrolling in the study, or they must be permanently sterile or otherwise of nonchildbearing potential. Female subjects must also not be breastfeeding. |
- Los pacientes deberán padecer hepatitis C crónica tipo 1a o 1b en la fase de selección. - El paciente deberá disponer de un diagnóstico de infección por VIH-1 > 6 meses antes de la fase de detección. - Administración de una de las pautas terapéuticas del TARGA permitidas para el VIH de forma continua >/=12 semanas antes del día 1, sin cambios. - Hombres y mujeres de entre 18 y 65 años, ambos incluidos. - Las mujeres no podrán estar embarazadas ni tener pensado quedarse embarazadas en las 72 semanas posteriores a su inclusión en el estudio o deberán ser estériles de forma permanente o no estar en edad fértil. Las mujeres tampoco podrán estar en período de lactancia. |
|
E.4 | Principal exclusion criteria |
- Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides - Evidence of hepatic decompensation - Clinical suspicion of acute hepatitis - Any other cause of liver disease in addition to hepatitis C - Diagnosed or suspected hepatocellular carcinoma - Pre-existing psychiatric condition - Medical condition that requires frequent or prolonged use of systemic corticosteroids - Previous treatment with an HCV protease inhibitor |
- Uso de nucleósidos de azidotimidina (AZT), didanosina (ddI) o estavudina (d4T). - Signos de descompensación hepática - Sospecha clínica de hepatitis aguda. - Cualquier otra causa de enfermedad hepática además de la hepatitis C. - Carcinoma hepatocelular diagnosticado o sospechado. - Enfermedad psiquiátrica preexistente. - Enfermedad que requiera un uso frecuente o prolongado de corticoesteroides sistémicos. - Tratamiento previo con un inhibidor de la proteasa del VHC. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug |
Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC tras 12 semanas desde la última dosis planificada del fármaco de estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study Week 60 |
Semana 60 del estudio. |
|
E.5.2 | Secondary end point(s) |
- Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) - Proportion of subjects who achieve undetectable HCV RNA at Week 4 (RVR), Week 4 and 12 (eRVR), and planned End of Treatment (EOT) - Safety as assessed by AEs, clinical laboratory results, HIV RNA assessments, CD4 counts, 12-lead electrocardiogram (ECGs), and vital signs - PK of telaprevir, Peg-IFN, RBV, and selected HAART medications - Amino acid sequence of the HCV NS3.4A protease region |
- Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC tras 24 semanas desde la última dosis planificada del fármaco de estudio (SVR24). - Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC en la semana 4 (RVR), en la semana 4 y 12 (eRVR) y al finalizar el tratamiento planificado (FDT). - Seguridad evaluada de acuerdo con los AA, los resultados analíticos, las evaluaciones del ARN del VIH, los recuentos de linfocitos CD4, los electrocardiogramas (ECG) de 12 derivaciones y las constantes vitales. - FC de telaprevir, Peg-IFN, ribavirina y fármacos del TARGA seleccionado. - Secuencia de aminoácidos de la región de la proteasa NS3.4A del VHC. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study Week 72 |
Semana 72 del estudio. |
|
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 | No |
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) | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 9 |
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 |
Mexico |
United States |
|
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
|
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 | 3 |
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 | 3 |
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 |