Clinical Trials Register

Summary
EudraCT Number:	2010-019585-90
Sponsor's Protocol Code Number:	WV21913
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:	2011-11-03
Trial results	Removed from public view

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

2010-019585-90

A.3

Full title of the trial

A Randomized, Open-label, Multicenter Study to Evaluate the Sustained
Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted
with Low Dose Ritonavir (Danoprevir/r) and Copegus®, in Combination
with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or
Pegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with a
Previous Course of Peginterferon alfa plus Ribavirin Combination
Therapy

Estudio aleatorizado, abierto, multicéntrico, para evaluar la respuesta virológica sostenida del inhibidor de proteasa VHC Danoprevir reforzado con Ritonavir en dosis bajas (DNV/r) y Copegus® en asociación con el profármaco inhibidor de polimerasa VHC RO5024048 y/o Pegasys® en pacientes con infección crónica por el virus de la hepatitis C genotipo 1 en los que ha fracasado el tratamiento previo con la asociación de interferón alfa pegilado mas ribavirina.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A research study of a new medicine, danoprevir, with ritonavir and
Copegus (also known as ribavirin), in combination with another new
medicine, RO5024048, and/or Pegasys for the treatment of a disease
called chronic hepatitis C, which causes damage to the liver, in patients
that failed a previous treatment for hepatitis C.

Estudio de investigación de un nuevo medicamento, danoprevir, con ritonavir y Copegus (también conocido como ribavirina), en combinación con otro nuevo medicamento, RO5024048, y/o Pegasys para el tratamiento de una enfermedad llamada hepatitis C crónica, que provoca daño en el hígado, en pacientes en los que ha fracasado un tratamiento previo para la hepatitis C.

A.3.2

Name or abbreviated title of the trial where available

Matterhorn

A.4.1

Sponsor's protocol code number

WV21913

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01331850

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F.Hoffmann-La Roche
B.1.3.4	Country	Switzerland
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	F.Hoffmann-LA Roche AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.6	E-mail	global.rochegenetechtrials@roche.com

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	Danoprevir
D.3.2	Product code	RO5190591/F24
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
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	Danoprevir
D.3.9.2	Current sponsor code	RO5190591
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	100
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	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	RO5024048
D.3.2	Product code	RO5024048/F14
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
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	-
D.3.9.1	CAS number	-
D.3.9.2	Current sponsor code	RO5024048
D.3.9.3	Other descriptive name	Profármaco Inhibidor de la Polimerasa del VHC
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	500
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	Pegasys
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
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 2A
D.3.9.1	CAS number	198153-51-4
D.3.9.2	Current sponsor code	RO0258310
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	180
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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: 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	COPEGUS 200 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE FARMA, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
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	RIBAVIRINA
D.3.9.1	CAS number	36791-04-5
D.3.9.3	Other descriptive name	RIBAVIRIN
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	Norvir
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott Laboratories Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.2	Current sponsor code	RO0326047
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	100
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Hepatitis C

Hepatitis C crónica

E.1.1.1

Medical condition in easily understood language

Viral infection called Hepatitis C which causes damage to the liver

Infección viral denominada Hepatitis C que provoca daño en el hígado

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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the sustained virological response of the following treatment
regimens:
- DNV/r with RO5024048 and Copegus® when administered for 24
weeks in patients with previous partial or null response to PEG-IFN/RBV
treatment.
- DNV/r with Pegasys® and Copegus® when administered for 24 weeks
in patients with previous partial response to PEG-IFN/RBV treatment.
- DNV/r and RO5024048 with Pegasy®s and Copegus® when
administered for 24 weeks in patients with previous partial or null
response to PEG-IFN/RBV treatment.
- DNV/r and RO5024048 with Pegasys® and Copegus® when
administered for 24 weeks followed by Pegasys® and Copegus®
administered for an additional 24 weeks in patients with previous null
response to PEG-IFN/RBV treatment.

Comparar la respuesta virológica sostenida de las siguientes pautas de tratamiento en pacientes en los que ha fracasado al tratamiento previo con la asociación de interferón alfa pegilado más ribavirina:
DNV/r con RO5024048 y Copegus® cuando se administra durante 24 semanas en pacientes con respuesta parcial o nula al tratamiento previo con IFN-PEG/RBV
DNV/r con Pegasys® y Copegus® cuando se administra durante 24 semanas en pacientes con respuesta parcial al tratamiento previo con IFN-PEG/RBV
DNV/r y RO5024048 con Pegasys ® y Copegus® cuando se administra durante 24 semanas en pacientes con respuesta parcial o nula al tratamiento previo con IFN-PEG/RBV
DNV/r y RO5024048 con Pegasys® y Copegus® cuando se administra durante 24 semanas seguido de Pegasys® y Copegus® administrado durante otras 24 semanas en pacientes con respuesta nula al tratamiento previo con IFN-PEG/RBV

E.2.2

Secondary objectives of the trial

- To compare the safety (incidence of adverse events) of the following
treatment regimens: danoprevir, RO5024048 and Copegus; danoprevir,
Pegasys and Copegus; danoprevir, RO5024048, Pegasys and Copegus.
- To determine virologic response over time
- To characterize the pharmacokinetics of DNV and RO5024048
- To characterize the resistance profile of DNV and RO5024048

Comparar la seguridad y tolerabilidad de las tres pautas de tratamiento siguientes:
DNV/r, RO5024048 y Copegus®, DNV/r, Pegasys® y Copegus® ,DNV/r, RO5024048, Pegasys y opegus®
Determinar la respuesta virológica a lo largo del tiempo (todas las visitas).
Caracterizar las características farmacocinéticas de DNV y RO5024048
Caracterizar el perfil de resistencia de DNV y RO5024048

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

Roche Clinical Repository Specimens (RCR)

Roche Clinical Repository Specimens (RCR); subestudio farmacocinético y muestras opcionales para el análisis IL28 y VHC. Para más detalles, ver protocolo WV21913.

E.3

Principal inclusion criteria

- Adult patients, age 18 years and older
- Presence of hepatitis C infection, genotype 1a or 1b
- Documentation of previous treatment failure after receiving approved
doses of peginterferon plus ribavirin for at least 12 weeks
- Patients must have discontinued prior hepatitis C treatment at least 12
weeks prior to study start

Pacientes de ambos sexos de 18 años o mayores.
Presencia de Infección por Hepatitis C, genotipo 1a o 1b
Documentación de fracaso terapéutico previo después del inicio del tratamiento con las dosis aprobadas de IFN-PEG más RBV. durante al menos 12 semanas.
Los pacientes deben haber suspendido el tratamiento previo para VHC al menos 12 semanas antes de ser incluidos (primera administración) en este estudio

E.4

Principal exclusion criteria

- Infection with any hepatitis C genotype or subtype other than genotype
1a or 1b
- Patients with cirrhosis
- Patients who were discontinued from previous peginterferon plus
ribavirin therapy due to reasons other than insufficient therapeutic
response
- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or evidence of chronic liver disease other than hepatitis C

Infección con cualquier subtipo o genotipo de VHC diferente a genotipo 1a o 1b.
Pacientes con cirrosis
Pacientes que se retiraron del tratamiento IFN-PEG/RBV previo por motivos diferentes a respuesta terapéutica insuficiente
Co-infección con hepatitis B o virus de la inmunodeficiencia humana (VIH)
Antecedentes u otras pruebas de una enfermedad asociada con la hepatopatía crónica diferente a VHC

E.5 End points

E.5.1

Primary end point(s)

The primary measure of efficacy is SVR-24 according to planned
treatment duration.

La variable principal de valoración de eficacia es RVS-24 de acuerdo con la duración prevista del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks after the planned end of treatment

24 semanas después del final del tratamiento previsto

E.5.2

Secondary end point(s)

- SVR-24 according to actual treatment duration, defined as the
percentage of patients with undetectable HCV RNA 20 weeks after the
actual end of treatment, as measured by Roche COBAS TaqMan HCV.
- Virological response at clinical visits over time, defined as the
percentage of patients with undetectable (< 25 IU/ml) HCV RNA as
measured by the Roche COBAS TaqMan HCV test
- Virological response at the end of treatment period, defined as the
percentage of patients with undetectable (< 25 IU/ml) HCV RNA as
measured by the Roche COBAS TaqMan HCV test at the last
administration of study medication
- Virological response at 12 weeks post treatment, defined as the
percentage of patients with undetectable HCV RNA as measured by the
Roche COBAS TaqMan HCV test at 12 weeks after the last dose of study
medication (SVR-12 according to actual treatment duration)
- Relapse rate, defined as the percentage of patients who achieved a
virological response at the end of treatment but had detectable HCV RNA
at the last assessment post treatment (among patients that had a
virological response at the end of treatment and had at least one HCV
RNA assessment post treatment)
- Virological breakthrough, defined as the percentage of patients who
achieved a virological response during treatment (viral load decline >
0.5 log10 followed by an increase of at least 0.5 log10 from on treatment
nadir) before the end of danoprevir/r or RO5024058 treatment.

- RVS-24 de acuerdo con la duración real del tratamiento,
definido como el porcentaje de pacientes con ARN VHC
indetectable ? 20 semanas después de la finalización real
del tratamiento, determinado por Roche COBAS TaqMan
VHC.
- Respuesta virológica en las visitas clínicas a lo largo del
tiempo, definida como el porcentaje de pacientes con ARN
VHC indetectable (< 25 UI/ml) determinado por Roche
COBAS TaqMan VHC test.
- Respuesta virológica en el final del periodo de tratamiento,
definido como el porcentaje de pacientes con ARN VHC
indetectable (< 25 UI/ml) determinado por Roche COBAS
TaqMan VHC test en la última administración del tratamiento
del estudio.
- Respuesta virológica en 12 semanas después del tratamiento,
definido como el porcentaje de pacientes con ARN VHC
indetectable determinado por Roche COBAS TaqMan VHC
test en 12 semanas después de la última administración del
tratamiento del estudio (RVS-12 de acuerdo con la duración
real del tratamiento)
- Tasa de recaída, definida como el porcentaje de pacientes que
consiguieron respuesta virológica al final del tratamiento
pero tenían ARN VHC detectable en la última valoración
posterior al tratamiento (entre los pacientes que tenían una
respuesta virológica al final del tratamiento y tenían al menos
una valoración ARN VHC posterior al tratamiento)
- Recaída virológica, definido como el porcentaje de pacientes
que consiguieron respuesta virológica durante el tratamiento
(disminución de la viremia > 0,5 log10 seguido de un
aumento de al menos 0,5 log10 desde el mínimo del
tratamiento) antes del final del tratamiento con danoprevir/r o
RO5024058.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks after the planned end of treatment. Up to four interim analyses
of efficacy and safety data may be performed to inform the clinical
development plan for RO5024048 and danoprevir. Interim analyses may
be performed (1) when at least 80% of patients have completed
approximately 12 weeks in the study, (2) when all patients have
completed at least 24 weeks in the study, (3) when all patients have
completed at least 36 weeks in the study, and (4) when all patients have
completed at least 12 weeks of treatment-free follow up.

24 semanas después del final del tratamiento previsto. Pueden realizarse un máximo de cuatro análisis de los datos de eficacia y seguridad para informar el plan de desarrollo clínico de RO5024048 y danoprevir. Los análisis intermedios pueden realizarse (1) cuando al menos el 80% de los pacientes han completado aproximadamente 12 semanas en el estudio, (2) cuando todos los pacientes han completado al menos 24 semanas en el estudio, (3) cuando todos los pacientes han completado al menos 36 semanas en el estudio, y (4) cuando todos los pacientes han completado al menos 12 semanas de seguimiento sin tratamiento.

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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.8.4.1

Number of sites anticipated in Member State concerned

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

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

Austria

Brazil

Canada

France

Germany

Italy

Mexico

Poland

Spain

United Kingdom

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

See protocol

Ver protocolo

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.1.2.1

Number of subjects for this age range:

395

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

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

160

F.4.2.2

In the whole clinical trial

420

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)

(see protocol)

(Ver protocolo)

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

2011-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-01-29

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Orphan Designation Number:
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