Clinical Trials Register

Summary
EudraCT Number:	2009-012072-28
Sponsor's Protocol Code Number:	MO22468
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:	2009-10-01
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

2009-012072-28

A.3

Full title of the trial

Estudio randomizado en fase IIIb de MabThera® (rituximab) agregado a quimioterápia, bendamustina o clorambucilo, en pacientes con leucemia linfática crónica.

A randomized Phase IIIb study of MabThera ® (rituximab) added to a chemotherapy, bendamustine or chlorambucil, in patients with Chronic Lymphocytic Leukemia.

A.3.2

Name or abbreviated title of the trial where available

RiBECCA

A.4.1

Sponsor's protocol code number

MO22468

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	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
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	MABTHERA 100 mg concentrado para solución para perfusión
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	Concentrate for solution for 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	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.3	Other descriptive name	RITUXIMAB
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	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	Yes
D.3.11.13.1	Other medicinal product type	Anticuerpo monoclonal humanizado recombinante.
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	LEUKERAN 2 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	WELLCOME FARMACEUTICA, 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	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	CLORAMBUCILO
D.3.9.1	CAS number	305-03-3
D.3.9.3	Other descriptive name	CHLORAMBUCIL
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	2
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: 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	Ribomustin®
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma GmbH
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	Powder for solution for 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	bendamustine hydrochloride
D.3.9.1	CAS number	16506-27-2
D.3.9.2	Current sponsor code	RO5469113
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	25
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: 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	MABTHERA 500 mg concentrado para solución para perfusión
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	Concentrate for solution for 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	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.3	Other descriptive name	RITUXIMAB
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	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	Yes
D.3.11.13.1	Other medicinal product type	Anticuerpo monoclonal humanizado recombinante.
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	Ribomustin®
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma GmbH
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	Powder for solution for 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	bendamustine hydrochloride
D.3.9.1	CAS number	16506-27-2
D.3.9.2	Current sponsor code	RO5469113
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	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

Pacientes con leucemia linfática crónica (LLC) en primera linea o segunda línea (máximo de una línea de tratamiento previa) con necesidad de tratamiento. (En España, solo se incluirán pacientes en segunda línea).

First line or second line (maximum of 1 line of previous treatment) patients with chronic lymphocytic leukemia (CLL) with need for treatment.

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	10008976
E.1.2	Term	Chronic lymphocytic leukemia

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 tasa de respuesta completa (RC) confirmada después de 6 ciclos de tratamiento entre los dos brazos de tratamiento, en los pacientes con LLC en primera y en segunda línea combinados. En España, solo se incluirán pacientes en segunda línea.

E.2.2

Secondary objectives of the trial

Confirmar aun más la efectividad de la adición de rituximab a bendamustina o clorambucilo en cuanto a las categorías de respuesta tumoral (tasa de respuesta global [TRG], respuesta completa [RC], RC con recuperación incompleta de la médula ósea (RCi), respuesta parcial [RP], respuesta parcial nodular [RPn], enfermedad estable [EE] o progresión de la enfermedad [PE]), supervivencia libre de progresión (SLP), supervivencia libre de enfermedad (SLE), supervivencia libre de eventos (SLEv), tiempo hasta el siguiente tratamiento de la leucemia (TSTL), duración de la respuesta, supervivencia global (SG), respuesta molecular y enfermedad mínima residual (EMR).
Evaluar la seguridad en cuanto a acontecimientos adversos (AA), acontecimientos adversos graves (AAG), análisis de laboratorio (hematología habitual, inmunoglobulinas y bioquímica clínica), peso, constantes vitales y exploración física.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Consentimiento informado por escrito, firmado y fechado.
2. 18 años o más de edad
3. Fenotipo de las células tumorales compatible con LLC: CD5+ CD20+ CD23+.
4. LLC activa en estadio B o C de Binet progresivo y con necesidad de tratamiento según los criterios del NCI de 2008 [Apéndice 5 del protocolo] (nota: sólo es necesario cumplir uno de los criterios anteriores).
5. Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤ 2 (véase el Apéndice 4 del protocolo).
6. No apto para recibir tratamiento con fludarabina. Los motivos pueden ser:
a) Procesos médicos concurrentes, como antecedentes de infecciones oportunistas o infecciones de grado 3 ó 4 reiteradas de otros tipos.
b) Pacientes con deterioro grave de la función de la MO (trombocitopenia, anemia o granulocitopenia), por motivos distintos a la enfermedad subyacente (LLC).
c) Inmunodeficiencia.
d) Ancianos (≥ 75 años), ya que hay datos limitados sobre el uso de fludarabina en esta población.
e) Antecedentes de procesos autoinmunitarios o resultado positivo en la prueba de Coombs.
f) Procesos autoinmunitarios (p. ej., anemia hemolítica autoinmune, trombocitopenia autoinmune, púrpura trombocitopénica, pénfigo o síndrome de Evans).
g) A criterio del médico a cargo del tratamiento.
7. Solo se permitirá el tratamiento previo con rituximab o clorambucilo.
8. Las mujeres en que no hayan transcurridos 2 años desde el inicio de la menopausia y que no estén esterilizadas quirúrgicamente deberán contar con una prueba de embarazo en suero negativa en la semana anterior al primer ciclo de tratamiento.

E.4

Principal exclusion criteria

1. Pacientes que hayan recibido tratamiento previo con rituximab o clorambucilo y que hayan recaído menos de 12 meses después de la primera dosis del tratamiento de primera línea.
2. Trasplante autólogo de células stem previo o previsto durante el estudio.
3. Trasplante alogénico de células stem previo o previsto durante el estudio.
4. Radioinmunoterapia en los 6 meses anteriores al inicio del tratamiento.
5. Cualquier otro tratamiento antineoplásico concurrente (p. ej., alquilantes, antimetabolitos, análogos de purina o anticuerpos monoclonales) o glucocorticoides a menos que se administren en dosis equivalentes a ≤ 20 mg de prednisolona/día. Se permite el uso de esteroides inhalados o tópicos.
6. Pacientes previamente tratados con ofatumumab.
7. Pacientes con transformación a formas tumorales agresivas de células B(p. ej., linfoma de células grandes B, síndrome de Richter o leucemia prolinfocítica de estirpe B [LPL]).
8. Afectación conocida o sospechada del sistema nervioso central (SNC) por la LLC.
9. Tumor maligno pasado o actual en los 2 últimos años antes de la selección, excepto:
a) Carcinoma de cuello uterino em estadio 1B o inferior.
b) Carcinoma basocelular y espinocelular no infiltrante.
c) Melanoma maligno con una RC de una duración > 10 años.
d) Otros diagnósticos de cáncer con una RC de una duración > 5 años.
10. Cirugía mayor (excepto biopsia ganglionar) en los 28 días anteriores al primer ciclo de tratamiento del estudio.
11. Enfermedad infecciosa crónica o activa en curso con necesidad de tratamiento sistémico, por ejemplo, osteomielitis.
12. Antecedentes de enfermedad cerebrovascular importante, por ejemplo, déficit neurológico isquémico reversible prolongado o accidente cerebrovascular (hemorrágico o isquémico).
13. Pacientes con infección conocida por el virus de la inmunodeficiencia humana (VIH) o con infección activa por el virus de la hepatitis B (VHB) o C (VHC).
14. Enfermedad subyacente grave que pueda afectar a la capacidad del paciente para participar en el estudio (p. ej., diabetes mellitus no controlada, úlceras gástricas, enfermedad autoinmune activa, hipertensión arterial no controlada o cardiopatía preexistente, enfermedad pulmonar obstructiva crónica grave con hipoxemia o disfunción orgánica importante [hígado, riñón]). Debe aplicarse el criterio del investigador.
15. Valores analíticos de selección: determinar todos los valores analíticos
a) Creatinina < 1,5 veces el límite superior de la normalidad [LSN].
b) Bilirrubina total > 1,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
c) Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 2,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
d) Fosfatasa alcalina > 2,5 veces el LSN (a menos que se deba a afectación hepática por la LLC).
16. Función hematológica inadecuada:
a) Recuento absoluto de neutrófilos (RAN) < 1,0 109/l, a menos que se deba a afectación de la MO por la LLC.
b) Recuento de plaquetas < 50 109/l, a menos que se deba a afectación de la MO por la LLC.
c) Hemoglobina < 9,0 g/dl, a menos que se deba a afectación de la MO por la LLC.
17. Hipersensibilidad conocida o sospechada a los componentes del producto en investigación (en particular, hipersensibilidad o reacción anafiláctica conocida a anticuerpos o proteínas murinas).
18. Esperanza de vida inferior a 6 meses.
19. Incapacidad conocida o sospechada del paciente para cumplir el protocolo del estudio.
20. Embarazo o lactancia.
21. Pacientes de ambos sexos en edad fértil no dispuestos a utilizar un método anticonceptivo eficaz (anticonceptivos orales, dispositivo intrauterino o método de barrera junto con gel espermicida o esterilización quirúrgica) durante el estudio y un año después de la última dosis de medicación del estudio.
22. Incapacidad de otorgar el consentimiento informado.
23. Citopenia autoinmune importante evaluada por el médico (los pacientes con una prueba de Coombs positiva sin signos clínicos de anemia hemolítica autoinmune son aptos para participar en el estudio).
24. Pacientes que han recibido un tratamiento en investigación en los 30 días anteriores a la selección.
25. Trastorno médico que requiere el uso crónico de corticosteroides orales.

E.5 End points

E.5.1

Primary end point(s)

El criterio de valoración principal es la tasa de RC confirmada (sí/no) después del tratamiento con 6 ciclos de fármaco del estudio (la definición de RC confirmada se facilita en la sección 5.3.2. del protocolo).

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

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

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.8.3

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

El final de la parte clínica del estudio es la fecha de la última visita del último paciente (UVUP), que se prevé aproximadamente para el tercer trimestre de 2013. Los pacientes serán objeto de seguimiento hasta la fecha límite de recogida de datos (en torno al tercer trimestre de 2013, o al mes 36, lo que ocurra antes)

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

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

550

F.4.2.2

In the whole clinical trial

660

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)

El seguimiento continuará hasta la fecha de corte (aproximadamente el tercer trimestre de 2013, o el mes 36, lo que ocurra antes).

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

2009-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-03-31

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