Clinical Trials Register

Summary
EudraCT Number:	2007-002445-20
Sponsor's Protocol Code Number:	A8851009
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:	2007-12-03
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

2007-002445-20

A.3

Full title of the trial

A PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE EFFICACY OF ANIDULAFUNGIN AND VORICONAZOLE IN COMBINATION TO THAT OF VORICONAZOLE ALONE WHEN USED FOR PRIMARY THERAPY OF PROVEN OR PROBABLE INVASIVE ASPERGILLOSIS

Estudio prospectivo y aleatorizado para comparar la eficacia de la combinación de anidulafungina y voriconazol con la del voriconazol solo cuando se usan para el tratamiento primario de la aspergilosis invasiva demostrada o probable.

A.4.1

Sponsor's protocol code number

A8851009

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	Pfizer, S.A.
B.1.3.4	Country	Spain
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	Yes
D.2.1.1.1	Trade name	Ecalta
D.2.1.1.2	Name of the Marketing Authorisation holder	EU/1/07/416/001
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	Anidulafungin
D.3.2	Product code	PF-03910960
D.3.4	Pharmaceutical form	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	166663-25-8
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)	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	Information not present in EudraCT
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	Vfend
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	Voriconazole
D.3.2	Product code	UK-109496
D.3.4	Pharmaceutical form	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	voriconazole
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	Information not present in EudraCT
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	Vfend
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	Voriconazole
D.3.2	Product code	UK-109496
D.3.4	Pharmaceutical form	Tablet
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	voriconazole
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	50
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	Information not present in EudraCT
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	Vfend
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	Voriconazole
D.3.2	Product code	UK-109496
D.3.4	Pharmaceutical form	Tablet
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	voriconazole
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	Information not present in EudraCT

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	Intravenous infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Aspergilosis invasiva.

INVASIVE ASPERGILLOSIS.

MedDRA Classification

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	10003488
E.1.2	Term	Aspergillosis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparar la muerte por todas las causas a las 6 semanas en pacientes con malignidades hematológicas o con un TCMH alogénico, con diagnóstico de AI probada o probable, que reciben voriconazol y anidulafungina en combinación frente a voriconazol en monoterapia.

E.2.2

Secondary objectives of the trial

• Comparar la respuesta global a las 6 semanas;
• Comparar la muerte por todas las causas a las 6 semanas en pacientes con malignidades hematológicas o con un TCMH alogénico y diagnóstico de AI posible, probada o probable (población IT) que reciben voriconazol y anidulafungina en combinación frente a voriconazol en monoterapia;
• Comparar la muerte por todas las causas a las 12 semanas en pacientes con malignidades hematológicas o con un TCMH alogénico y diagnóstico de AI probada o probable que reciben voriconazol y anidulafungina en combinación frente a voriconazol en monoterapia;
• Comparar el tiempo hasta la muerte (por cualquier causa) en pacientes con malignidades hematológicas o con un TCMH alogénico y diagnóstico de AI probada o probable que reciben voriconazol y anidulafungina en combinación frente a voriconazol en monoterapia;
• Comparar la seguridad y la tolerabilidad de voriconazol en monoterapia con la del voriconazol en combinación con anidulafungina;

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Estado inmunocomprometido debido a:
• Recepción de un trasplante alogénico de células madre hematopoyéticas después de acondicionamiento mieloablativo o no-mieloablativo; o
• Malignidad hematológica (excepto sujetos con enfermedad hematológica progresiva que no hayan respondido (o que no tengan probabilidades de responder) al tratamiento);
2. Diagnóstico de aspergilosis invasiva probada, probable o posible (basado en una versión modificada de las definiciones consensuadas de la EORTC/MSG)
• NOTA: Los sujetos reclutados que tengan AI posible deberán presentar un diagnóstico probado o probable dentro de los 7 días posteriores al reclutamiento.
La aspergilosis invasiva probada se define como:
• Examen histopatológico, citopatológico o microscópico directo de una aspiración con aguja o una biopsia que muestre hifas con evidencia de lesión tisular asociada (ya sea microscópica o en forma de infiltrado o una lesión en estudios de imagen);
o,
• Recuperación de especies de Aspergillus en cultivo de muestra obtenida mediante un procedimiento estéril de un lugar normalmente estéril y anormal desde el punto de vista clínico o radiológico, compatibles con una enfermedad infecciosa, excepto LBA, cavidad de los senos craneales, y orina.
La aspergilosis invasiva probable se define por al menos:
• Un criterio del huésped; y
• Un criterio clínico; y
• Un criterio microbiológico.
La aspergilosis invasiva posible se define por al menos:
• Un criterio del huésped; y uno de los siguientes
• Un criterio clínico; o
• Un criterio microbiológico.
3. Sujetos de ambos sexos, de edad >= 16 años.
4. Para mujeres en edad fértil, el paciente debe tener una prueba de embarazo negativa en suero u orina.
5. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, conforme a los requisitos legales y regulatorios locales, en el que se indique que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio.
6. Sujetos dispuestos a cumplir con las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y capaces de hacerlo.

E.4

Principal exclusion criteria

1. Antecedentes conocidos de alergia, hipersensibilidad o reacción grave a los antifúngicos azólicos o las equinocandinas;
2. Pacientes embarazadas o lactantes;
3. Pacientes con sarcoidosis, aspergiloma, o aspergilosis broncopulmonar alérgica (ABA);
4. Pacientes con aspergilosis invasiva crónica con una duración de los síntomas o hallazgos radiológicos mayor de 4 semanas antes de la entrada en el estudio;
5. Pacientes que estén recibiendo los siguientes medicamentos y no puedan suspenderlos al menos 24 horas antes de la aleatorización: terfenadina, astemizol, cisaprida, pimozida o quinidina (dada la posibilidad de prolongación de QT);
6. Pacientes en tratamiento con cualquiera de los medicamentos siguientes: sirolimus, rifampicina, rifabutina, carbamazepina, barbitúricos de acción prolongada (p. ej., fenobarbital, mefobarbital), ritonavir, efavirenz o alcaloides ergotamínicos (p. ej., ergotamina, dihidroergotamina);
7. Existen otras interacciones entre el voriconazol y algunos fármacos recetados habitualmente que pueden tener relevancia clínica. Aunque estos medicamentos no están contraindicados, en el Apéndice 2 se ofrecen consejos para controlar o ajustar la dosis.
8. Haber recibido 4 o más días de tratamiento antifúngico sistémico para el episodio actual de aspergilosis invasiva.
NOTA: podrán incluirse los pacientes que reciban profilaxis con itraconazol, voriconazol o posaconazol, siempre y cuando cumplan los criterios de AI probada o probable en el momento del reclutamiento. Estos sujetos deberán recibir la formulación IV de voriconazol durante las dos primeras semanas del estudio.
9. Disfunción hepática grave (definida como un valor de bilirrubina total, AST, ALT o fosfatasa alcalina >5 veces el límite superior de la normalidad). Podrán utilizarse los resultados del laboratorio local para verificar que los sujetos pueden ser aleatorizados. Sin embargo, si los valores analíticos obtenidos en la visita basal superan los límites anteriores de exclusión, se establecerá contacto sin demora con el monitor médico para decidir sobre la continuación del tratamiento del estudio;
10. Pacientes en ventilación artificial, con pocas probabilidades de ser extubados en las 24 horas siguientes a la entrada en el estudio;
11. Pacientes con cualquier enfermedad que, en opinión del investigador, pueda afectar a la seguridad del paciente, impedir la evaluación de la respuesta o hacer improbable que pueda completarse el ciclo de tratamiento propuesto;
12. Pacientes que estén recibiendo, o que probablemente vayan a recibir, un fármaco o tratamiento en investigación durante el estudio;
13. Pacientes que hayan participado anteriormente en el ensayo o en otro estudio distinto en los últimos 30 días;
14. Pacientes que no se espera que sobrevivan al menos 5 días o que tengan una puntuación <=30 en la escala de Karnofsky;
15. Pacientes con una probabilidad elevada de morir debido a algún factor no relacionado con la aspergilosis (p. ej., por un tumor maligno recidivante, enfermedad grave de injerto contra huésped, otras enfermedades subyacentes, etc.) en los 30 días siguientes al día de reclutamiento previsto (criterio del investigador);
16. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier alteración analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interferir en la interpretación de los resultados del estudio y, en opinión del investigador, haga al sujeto no elegible para participar en este estudio.

E.5 End points

E.5.1

Primary end point(s)

El criterio de valoración principal es la muerte por todas las causas, medida 6 semanas después del diagnóstico de AI, en sujetos con AI probada o probable.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Information not present in EudraCT

E.6.2

Prophylaxis

Information not present in EudraCT

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Information not present in EudraCT

E.6.7

Pharmacodynamic

Information not present in EudraCT

E.6.8

Bioequivalence

Information not present in EudraCT

E.6.9

Dose response

Information not present in EudraCT

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Information not present in EudraCT

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Anidulafungin is double blinded but Voriconazole is not blinded at all

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Anidulafungin and Voriconzaole is a combination versus Voriconazole alone.

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

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

The End of the Trial is the Last Visit Last Subject.

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.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	Yes
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	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	35
F.4.2	For a multinational trial
F.4.2.1	In the EEA	390
F.4.2.2	In the whole clinical trial	335

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

2007-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-05-12

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