E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis type C (genotype I) virus infection |
Infección del virus de hepatitis C crónica de genotipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Liver disease caused by hepatitis C virus infection |
Enfermedad de Hígado causado por la infección del 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 | 14.1 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
|
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 determine weight based doses of boceprevir for children 17 to 3 years of age. |
Determinar las dosis basadas en el peso de boceprevir para niños de 17 a 3 años |
|
E.2.2 | Secondary objectives of the trial |
to evaluate the safety and tolerability of a single dose of boceprevir in children 17 to 3 years of age. |
Evaluar la seguridad y la tolerabilidad de una dosis única de boceprevir en niños de 17 a 3 años. |
|
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 DNA sample obtained in this clinical trial is going to be used to study various genetic causes of subjects' responses to a drug |
La muestra de ADN obtenida en este ensayo se utilizará para estudiar diversas causas genéticas de las respuestas de los sujetos a un fármaco |
|
E.3 | Principal inclusion criteria |
Key Inclusion Criteria: 1) Subjects must be 17 to 3 years of age (inclusive) at screening. 2) Subjects must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the Screening visit must confirm genotype 1 infection. 3) Subjects may be treatment naïve or have failed previous (peg)interferon/ribavirin treatment, and may be cirrhotic or non-cirrhotic |
Criterios de Inclusión: 1) Los pacientes deberán tener entre 17 y 3 años de edad (ambos inclusive) en la selección. 2) Los pacientes deben tener una HCC de genotipo 1 documentada previamente. Los pacientes con otros genotipos o con genotipos mixtos no podrán participar. El resultado de ARN del VHC en la visita de selección debe confirmar la infección por el virus de genotipo 1. 3) Podrá tratarse de pacientes sin tratamiento previo o con fracaso del tratamiento previo con (peg)interferón/ribavirina y con o sin cirrosis. |
|
E.4 | Principal exclusion criteria |
Key Clinical Exclusion Criteria:
1) Subjects known to be co-infected with the human immunodeficiency virus (HIV) and hepatitis B virus (HBaAg positive). 2) Subjects must not have received treatment with RBV within 90 days or any interferon-alpha within 30 days prior to screening, or currently be receiving antiviral/immunomodulatory treatment for hepatitis C. 3) Subjects must not have received previous treatment with a HCV protease inhibitor.
Key Laboratory Exclusion Criteria ? Hematologic criteria (growth factors may not be used to achieve study entry requirements): o Hemoglobin < lower limit of normal range (LLN) o Neutrophils <1500/mm3 o Platelets <100,000/mm3 ? Serum albumin < lower limit of normal (LLN) of laboratory reference range. ? Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions: o The subject may be enrolled if clinically euthyroid, AND o The euthyroid function is confirmed by thyroxine/triiodothyronine (T4/T3) testing ? Serum creatinine > ULN of laboratory reference range |
Criterios de Exclusión fundamentales: 1) Pacientes con coinfección conocida por el virus de la inmunodeficiencia humana (VIH) o el virus de la hepatitis B (HBsAg positivo). 2) Los pacientes no podrán haber recibido tratamiento con RBV en los 90 días anteriores ni ningún interferón alfa en los 30 días anteriores a la selección, ni estar recibiendo tratamiento antiviral/inmunomodulador contra la hepatitis C. 3) Los pacientes no podrán haber recibido tratamiento previo con un inhibidor de la proteasa del VHC. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
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 | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
to determine weight based doses of boceprevir for children |
Determinación de dosis de boceprevir en niños |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 |
Germany |
Poland |
Russian Federation |
Spain |
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
|
Last subject last visit |
LVLS. El último paciente de la última visita |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 6 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 6 |