Clinical Trials Register

Summary
EudraCT Number:	2006-002473-47
Sponsor's Protocol Code Number:	NV20235
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:	2012-03-15
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

2006-002473-47

A.3

Full title of the trial

Estudio multicéntrico, randomizado, doble-ciego, controlado con placebo de oseltamivir vs placebo en el tratamiento profiláctico de la gripe en pacientes inmunocomprometidos

A.3.1

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

Estudio de Tamiflu vs placebo en el tratamiento profiláctico de la gripe en pacientes inmunocomprometidos

A.4.1

Sponsor's protocol code number

NV20235

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 Ltd.
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 Ltd.
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.5.4	Telephone number	+41-61-688 1111
B.5.5	Fax number	+41-61-6919391
B.5.6	E-mail	global.rochegenentechtrials@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	Yes
D.2.1.1.1	Trade name	Tamiflu
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Capsule, hard
D.3.4.1	Specific paediatric formulation	Yes
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	oseltamivir phosphate
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	75
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	Yes
D.2.1.1.1	Trade name	Tamiflu
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	oseltamivir phosphate
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for oral suspension
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

Profilaxis estacional de la gripe en pacientes inmunocomprometidos

E.1.1.1

Medical condition in easily understood language

Profilaxis estacional de la gripe en pacientes inmunocomprometidos

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	PT
E.1.2	Classification code	10022000
E.1.2	Term	Influenza
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

El objetivo principal es evaluar prospectivamente la eficacia de oseltamivir en la profilaxis estacional determinada por la incidencia relativa de la gripe clínica confirmada por laboratorio en los dos grupos de tratamiento.

E.2.2

Secondary objectives of the trial

Los objetivos secundarios del estudio son evaluar:

? Evaluar la eficacia de oseltamivir en la profilaxis estacional de la gripe determinada por la incidencia relativa de la influenza en los dos grupos de tratamiento.
? Evaluar la seguridad de la profilaxis con oseltamivir en poblaciones inmunodeprimidas determinada por una revisión de los acontecimientos adversos, los parámetros analíticos, las constantes vitales y la exploración física en los dos grupos de tratamiento.
? Evaluación de todas las cepas clínicas para determinar la resistencia fenotípica y, cuando sea necesario, la genotípica.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Edad igual o superior a 1 año
?Prueba diagnóstica rápida negativa de la gripe en el nivel basal
?Individuo inmunocomprometido definido por:
Receptor de un TOS (hígado, riñón o ambos) O
Receptor de un TCPH alogénico
?Progenitor / tutor dispuesto y capaz de cumplir con los requisitos del estudio y otorgar su consentimiento (límite de edad marcada por cada país)
?Paciente capaz de cumplir con los requisitos del estudio y estar dispuesto a otorgar su aceptación (para menores, límite de edad marcada por cada país), como proceda.
?En el caso de participantes adultos, deberán estar dispuestos y poder comprender y otorgar su consentimiento informado por escrito.
?Las personas pertenecientes a un grupo de edad con capacidad reproductiva deberán acceder a usar un método anticonceptivo eficaz durante todo el periodo del estudio y durante un ciclo reproductivo tras el cese de la terapia del estudio.
?Las mujeres en edad fértil deberán tener un resultado negativo en la prueba de embarazo antes de comenzar a tomar la medicación del estudio.
?Deberán estar recibiendo una terapia inmunosupresora o, en opininión del investigador, su sistema inmunológico no está restablecido.

E.4

Principal exclusion criteria

?Síntomas que sugieran una enfermedad pseudogripal, incluyendo, aunque no limitados a fiebre, tos o congestión nasal.
?Pacientes con fiebre (temperatura > ó = 37.8 ºC)
?Vacuna antigripal en las 4 semanas previas a la distribución aleatoria
?Prueba diagnóstica rápida positiva para la gripe
?TOS en los 6 meses anteriores al momento de la distribución aleatoria
?TOS distinto del hígado, riñón o hígado y riñón
?El investigador opina que el paciente ha experimentado un rechazo agudo en las 4 semanas previas a la distribución aleatoria.
?Pacientes sometidos a un TCPH sin evidencia de prendimiento (el prendimiento se define como el punto en el que un paciente puede mantener un recuento absoluto de neutrófilos [RAN] sostenido de > 500/mm3 y un recuento de plaquetas sostenido de > o = 20.000/mm3, que dure > o = 3 días consecutivos sin transfusiones).
?Individuos sometidos a un TCPH a los que no se les ha dado el alta hospitalaria tras su hospitalización inicial para el trasplante.
?Evidencia de enfermedad veno-oclusiva, enfermedad de injerto contra huésped extensiva aguda o crónica [Apéndice 1].
?Tratamiento actual o previo (en los 6 meses previos a la distribución aleatoria) con anticuerpos monoclonales reductores de linfocitos (ejemplo, globulina antitimocítica, globulina antilinfocítica)
?Pacientes con otras afecciones co-mórbidas que pudieran afectar a la supervivencia del paciente o a la funcionalidad del injerto, entre las que se incluyen, aunque no están limitadas a: enfermedad linfoproliferativa post-trasplante (ELPT), una enfermedad autoinmune que incluye la enfermedad intestinal inflamatoria y psoriasis, enfermedad tiroidea sin tratar y una infección activa significativa.
?Aclaramiento de la creatinina < 10 ml/min en adultos o < 10 ml/min/1.73 M2 en niños (ecuación de Cockroft-Gault para adultos y ecuación de Schwartz para niños [Apéndice 1])
?Pacientes que estén recibiendo en la actualidad cualquier forma de terapia renal sustitutiva incluyendo hemodiálisis, diálisis peritoneal o hemofiltración.
?Evidencia de infecciones oportunistas activas o incontroladas (bacterianas, fúngicas o víricas ? incluido el citomegalovirus [CMV] o el virus del polioma [BKV]) en el momento de la distribución aleatoria. No se excluirá a los pacientes con VHC o VHB.
?Pacientes con una infección conocida por VIH
?Pacientes sometidos a evaluación o tratamiento por un proceso maligno activo (distinto del proceso maligno para el que se ha realizado un TOS o TCPH) en el momento de la distribución aleatoria.
?Enfermedad vascular, neurológica o pulmonar sin controlar. Una enfermedad sin controlar se define como cualquier enfermedad que requiera un cambio de terapia o una hospitalización en las 4 semanas previas a la distribución aleatoria. El cambio de terapia se define como un aumento de la dosis o un cambio de la medicación.
?Pacientes con diarrea severa u otros trastornos gastrointestinales que pudieran interferir con su capacidad de absorber medicamentos orales, incluidos pacientes diabéticos con una gastroenteropatía diabética previamente diagnosticada.
?Alergia a la medicación del estudio
?Intolerancia a la fructosa hereditaria (para individuos que tomen la formulación líquida)
?Tratamiento antivírico (por ejemplo: amantadina, rimantadina, zanamavir, oseltamivir y ribavirina) para la gripe en las 2 semanas previas a la distribución aleatoria.
?Pacientes que tomen el medicamento probenecid
?Pacientes embarazadas o amamantando
?Pacientes que participen en un ensayo clínico o en un ensayo de acceso ampliado con un fármaco experimental en las 4 semanas previas a la distribución aleatoria o al mismo tiempo que este estudio.

E.5 End points

E.5.1

Primary end point(s)

Proporción de pacientes con gripe clínica confirmada por laboratorio en los dos grupos de tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 semanas de profilaxis, 4 semanas de seguimiento

E.5.2

Secondary end point(s)

Evaluar la eficacia de oseltamivir en la profilaxis estacional de la gripe.

Evaluar la seguridad de oseltamivir en pacientes inmunocomprometidos en la profilaxis estacional de la gripe clínica confirmada por laboratorio.

Evaluación de las cepas clínicas para determinar la resistencia fenotípica y, cuando sea necesario, genotípica.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 semanas de profilaxis, 4 semanas 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

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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)

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

El estudio supone 84 días de tratamiento con una visita de seguimiento 28 días después.

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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 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 2012-03-15.

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

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

215

F.4.2.2

In the whole clinical trial

470

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)

N/A

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

2006-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-11-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-06-03

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