Clinical Trials Register

Summary
EudraCT Number:	2007-005508-42
Sponsor's Protocol Code Number:	P05216
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-07-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2007-005508-42

A.3

Full title of the trial

"Estudio Fase 3 de Seguridad y Eficacia de Boceprevir en Pacientes con Hepatitis C Crónica Genotipo 1 No Tratados Previamente."

"A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1."

A.4.1

Sponsor's protocol code number

P05216

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Schering-Plough Research Institute, a Division of Schering Corporation
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Boceprevir
D.3.2	Product code	SCH 503034
D.3.4	Pharmaceutical form	Capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Boceprevir
D.3.9.2	Current sponsor code	SCH 503034
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PegIntron
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Plough Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PegIntron
D.3.2	Product code	SCH 54031
D.3.4	Pharmaceutical form	Injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	peginterferon alfa-2b
D.3.9.1	CAS number	215647-85-1
D.3.9.2	Current sponsor code	SCH 54031
D.3.9.3	Other descriptive name	PegIntron
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Rebetol
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Plough Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Rebetol
D.3.2	Product code	SCH 18908
D.3.4	Pharmaceutical form	Capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ribavirin
D.3.9.2	Current sponsor code	SCH 18908
D.3.9.3	Other descriptive name	Rebetol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Information not present in EudraCT
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PegIntron
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Plough Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PegIntron
D.3.2	Product code	SCH 54031
D.3.4	Pharmaceutical form	Injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	peginterferon alfa-2b
D.3.9.1	CAS number	215647-85-1
D.3.9.2	Current sponsor code	SCH 54031
D.3.9.3	Other descriptive name	PegIntron
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PegIntron
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Plough Europe
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PegIntron
D.3.2	Product code	SCH 54031
D.3.4	Pharmaceutical form	Injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	peginterferon alfa-2b
D.3.9.1	CAS number	215647-85-1
D.3.9.2	Current sponsor code	SCH 54031
D.3.9.3	Other descriptive name	PegIntron
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PegIntron
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Plough Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PegIntron
D.3.2	Product code	SCH 54031
D.3.4	Pharmaceutical form	Injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	peginterferon alfa-2b
D.3.9.1	CAS number	215647-85-1
D.3.9.2	Current sponsor code	SCH 54031
D.3.9.3	Other descriptive name	PegIntron
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule*
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hepatítis C Crónica.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic hepatitis C

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10019744
E.1.2	Term	Hepatitis C

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	SOC
E.1.2	Classification code	10019805
E.1.2	Term	Hepatobiliary disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo primerio de este estudio es comparar la eficacia de dos regímenes terapéuticos de boceprevir a una dosis de 800 mg tres veces por día (TID) vía oral (PO) (en adelante denominado boceprevir) en combinación con PegIntrón 1.5 µg/kg semanalmente (QW) vía subcutánea (SC) más ribavirina dosificada según peso (WBD) (de 600 mg/día a 1400 mg/día) vía oral (PO) (en adelante denominado PEG + RBV [WBD]) frente a una terapia sólo de PEG + RBV [WBD] en sujetos adultos no tratados con hepatítis C crónica (HCC).

E.2.2

Secondary objectives of the trial

Los objetivos secundarios de ambas partes del estudio son:
• Evaluar la seguridad de boceprevir cuando se administra junto a PEG + RBV (WBD).
• Definir los factores de predicción de la respuesta virológica sostenida (SVR) tales como factores epidemiológicos, características de la enfermedad y respuesta al tratamiento.
• Desarrollar una relación entre el estado estacionario de los parámetros farmacocinéticos, obtenidos de la población basada en un modelo farmacocinético y las respuestas de un subgrupo de sujetos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnóstico y Criterios de Inclusión: Se elegirán para este estudio sujetos adultos con Hepatítis C Crónica (HCC) VHC genotipo 1 que no hayan recibido tratamiento previo para la HCC.
Los sujetos deben cumplir TODOS los criterios detallados a continuación para participar:
Criterios de Inclusión para HCC:
1. Los sujetos deben presentar una infección de HCC genotipo 1 documentada. Los resultados del ARN-VHC obtenidos en el laboratorio central en la visita de selección deben confirmar el genotipo 1 de la infección y debe ser ≥10,000 IU/mL.
2. Los sujetos deben tener una biopsia de hígado con histología consecuente con Hepatitis C Crónica sin ninguna otra etiología. Copias del informe de patología y las muestras de histología se requieren para la inclusión del paciente en el estudio. Las muestras de histología y el informe de patología deben estar disponibles en el centro antes de la randomización del sujeto. Son preferibles dos muestras de tejido sin teñir; sin embargo, se aceptará una muestra teñida con hematoxilina-eosina (H&E) más una muestra teñida con Tricrómico de Masson's (Masson's trichrome), las muestras deberán ser revisadas por el investigador para confirmar que son adecuadas.
a. No cirrosis: la biopsia debe estar realizada dentro de los 3 años anteriores a la Visita de Screening. Para las biopsias de más de 18 meses anteriores a la Visita de Screening se realizarán pruebas para marcadores de fibrosis para evaluar el nivel de fibrosis.
b. Cirrosis: cualquier biopsia histórica que demuestre cirrosis será suficiente independientemente del tiempo que haya transcurrido desde la biopsia.
c. A los sujetos cuya biopsia no cumpla estos criterios de tiempo se les podrá realizar una biopsia entre la Visita de Screening y el Día 1 una vez que las evaluaciones del screening confirmen que el sujecto cumple los criterios de inclusión.
3. Los sujetos con fibrosis en puentes o cirrosis deben tener una ecografía realizada en los 6 meses previos a la Visita de Screening (o entre la Visita de Screening y el Día 1) sin hallazgos sospechosos de carcinoma hepatocelular (CHC).
Criterios Generales de Inclusión:
4. Los sujetos deben ser de 18 años de edad o mayores.
5. Los sujetos deben pesar entre 40 kg y 125 kg.
6. El sujeto y su pareja(s) deben acordar el uso de métodos anticonceptivos fiables tal y como se especifica en la Sección 7.6.1 del protocolo, durante al menos 2 semanas antes del Día 1 y continuar hasta al menos 6 meses después de la última dosis del medicamento del estudio, o durante más tiempo si así lo indica la legislación local.
7. Los sujetos deben estar dispuestos a dar su consentimiento por escrito.

E.4

Principal exclusion criteria

(Se resumen los principales)
-Sujetos con co-infección conocida de VIH o virus de la hepatitis B (HBsAg positivo)
o infectados con genotipos del VCH distintos del genotipo 1 (incluyendo genotipos mixtos).
- Sujetos que recibieron tratamiento previo para la hepatitis C; que no fuesen remedios herbales exceptuando aquellos de los que se conoce su hepatotoxicidad (que son criterio de exclusión). Cualquier remedio herbal utilizado para el tratamiento de la hepatitis C debe suspenderse antes del Día 1. Sólo la silimarina (cardo mariano) está permitida durante el estudio.
- El tratamiento con cualquier fármaco en investigación en los 30 días previos a la visita de randomización en este estudio.
- La participación en otro ensayo clínico en los 30 días previos a la randomización, o la intención de participar en otro ensayo clínico durante la participación en este estudio.
-Evidencia de enfermedad descompensada del hígado que incluya pero no se limite a historia de presencia de ascitis, varices hemorrágicas, o encefalopatía hepática.
-Sujetos diabéticos o hipertensos con hallazgos en el examen ocular clínicamente significativos según se define en el protocolo.
-Condición(es) psiquiátrica(s) pre-existente según se define en el protocolo
-Diagnóstico clínico de drogodependencia según se define en el protocolo según tipo de sustancia y tiempo.
-Como se define más adelante en el protocolo, cualquier condición médica pre-existente que pueda interferir en la participación y cumplimiento del paciente con el estudio, incluyendo pero no limitado a:
a. Traume del Sistema Nervisos Central(SNC)
b. Historia actual de ataques epilépticos
c. Historia de ictus o ataque isquémico transitorio
d. Enfermedad mediada inmunológicamente
e. Enfermedad crónica pulmonar
f. Historia cardíaca actual o cualquier anomalía o disfunción cardíaca significativa
g.Cualquier condición médica que requiera, o sea probable que requiera, administración crónica sistémica de corticoesteroides durante el transcurso del estudio
h.Gota clínicamente activa en el año previo
i.Hemoglobinopatía
j.Síndormes Mielodisplásicos
k.Coagulopatía
l.Transplante de órganos (incluyendo transplante de células hematopoyéticas) distinto de transplante de córnea y pelo
m.Acceso venoso pobre que impida la recogida de muestras de sangre periférica de rutina que se requieren para este estudio
n.Sujetos con un catéter intravenoso permanente
o.Sujetos con historia de cirugía gástrica (ej. grapas, bypass) o sujetos con historia de desórdenes de malabsorción
-Evidencia de cancer o sospecha de cancer, o historia de cancer dentro de los 5 años anteriores (excepto carcinoma basal in situ o carcinoma de células de la piel tratado adecuadamente). Sujetos bajo evaluación por sospecha de cancer no son elegibles.
-Sujetos que estén embarazadas o amamantando.Sujetos con intención de quedar embarzadas durante el periodo del estudio.Hombres cuya pareja esté o tenga intención de quedarse embarazada durante el perido del estudio
-Criterios hematológicos, bioquímicos, y serológicos (no se podrán utilizar factores de crecimiento para alcanzar los requerimientos para la entrada en el estudio):
a.hemoglobina <12g/dL para mujeres y <13 g/dL para hombres
b.Neutrófilos <1500/mm3 (personas de raza negra:<1200/mm3)
c.Plaquetas <100.000/mm3
d.Bilirrubina Directa >1.5 por encima del límite normal (ULN) del rango de referencia del laboratorio. Bilirrubina Total >1.6 mg/dL a no ser que el paciente tenga historia de Enfermedad de Gilbert. Si la enfermedad de Gilbert es considerada la etilogía se debe documentar en la historia médica del paciente.
-Glucosa sérica
a. para sujetos no diagnosticados previamente de diabetes mellitus
1). ≥140 mg/dL (no-en ayunas) a menos que HbA1c ≤7% O
2). ≥100 mg/dL (en ayunas) a menos que HbA1c ≤7%
b. Para sujetos diagnosticados previamente de diabetes, HbA1c >8.5%
-PT (tiempo de protrombina)/PTT values >10% por encima del rango de referencia del laboratorio

E.5 End points

E.5.1

Primary end point(s)

El objetivo primario de eficacia es lograr una respuesta virológica sostenida (SVR) definida por una concentración plasmática indetectable de ARN-VHC en la semana 24 de la fase de seguimiento. Se declararán como fallos de tratamiento a aquellos sujetos que cumplan una de las siguientes características:
• Sujetos en cualquier brazo de tratamiento que presenten ARN-VHC detectable en la semana 24 de la fase de seguimiento.
• Sujetos en cualquier brazo de tratamiento que presenten ARN-VHC detectable en la semana 24 del tratamiento.
• Sujetos en cualquier brazo de tratamiento a los que les falte la determinación de ARN-VHC en la semana 24 de la fase de seguimiento pero que presentase ARN-VHC detectable en la semana 12 de la fase de seguimiento.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

interferon responses (RNA)

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Information not present in EudraCT

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

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

Última visita del último paciente (Last Subject Last Visit).

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-04.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

1060

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

A todos los pacientes que hayan recibido al menos una dosis de boceprevir se les ofrecerá la posibilidad de participar en un estudio de seguimiento a largo plazo de 3 años (P05063) tras completar su participación en este estudio. Los pacientes del brazo control con ARN-VHC detectable en la semana 24 de la fase de seguimiento serán elegibles para participar en un estudio de acceso expandido (P05514) y recibir boceprevir + PEG 1.5 mcg/kg/semana + RBV durante 44 semanas.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2008-09-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-08-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-19

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