Clinical Trials Register

Summary
EudraCT Number:	2011-000437-36
Sponsor's Protocol Code Number:	AI438011
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:	2011-07-27
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

2011-000437-36

A.3

Full title of the trial

A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety,
Efficacy and Dose-response of BMS-663068 in Treatment-experienced HIV-1 Subjects,
Followed by an Open-label Period on the Recommended Dose

Ensayo fase IIb aleatorizado, controlado y parcialmente ciego para investigar la seguridad, la eficacia y la relación dosis-respuesta de BMS-663068 en el tratamiento de sujetos infectados por el VIH-1 tratados previamente, seguido de un período en régimen abierto con la dosis recomendada

A.3.1

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

This clinical research study will assess the effectiveness (how well it works), safety, tolerability (how well the body stands the drug) and blood levels of combined doses of BMS-663068, Raltegravir and Tenofovir.

Este estudio de investigación clínica evaluará la eficacia (lo bien que funciona), la seguridad,la tolerabilidad (lo bien que el cuerpo "soporta" el medicamento) y los niveles en sangre de dosis combinadas de BMS-663068, Raltegravir y Tenofovir.

A.4.1

Sponsor's protocol code number

AI438011

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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.3.2	Product code	BMS-663068-03
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.3.9.1	CAS number	864953-39-9
D.3.9.2	Current sponsor code	BMS-663068-03
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	400
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.3.2	Product code	BMS-663068-03
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.3.9.1	CAS number	864953-39-9
D.3.9.2	Current sponsor code	BMS-663068-03
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	600
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	Reyataz
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol Myers Squibb Company
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Atazanavir
D.3.2	Product code	BMS-232632
D.3.4	Pharmaceutical form	Capsule, hard
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	ATAZANAVIR SULFATE
D.3.9.1	CAS number	229975-97-7
D.3.9.2	Current sponsor code	BMS-232632
D.3.9.4	EV Substance Code	SUB20595
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	300
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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	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.3.2	Product code	J05AE03
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	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.4	EV Substance Code	SUB10342MIG
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
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	Film-coated tablet
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

Human immunodeficiency virus type 1 (HIV-1)-infection

Virus de inmunodeficiencia humana tipo 1 (VIH-1) - infección

E.1.1.1

Medical condition in easily understood language

HIV infection

Infección por VIH

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	PT
E.1.2	Classification code	10020161
E.1.2	Term	HIV infection
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 assess the efficacy of four doses of BMS-663068 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24

To assess the safety of four doses of BMS-663068 in treatment-experienced HIV-1-infected subjects through Week 24 by measuring frequency of SAEs, and AEs leading to discontinuations.

Evaluar la eficacia de cuatro dosis de BMS-663068 mediante la determinación de la proporción de sujetos con un ARN del VIH-1 en plasma < 50 copias/ml en la semana 24.

Evaluar la seguridad de 4 dosis de BMS-663068 en sujetos infectados por el VIH-1 tratados previamente hasta la semana 24 mediante la medición de la frecuencia de acontecimientos adversos graves (AAG) y acontecimientos adversos (AA) que motiven la suspensión del tratamiento.

E.2.2

Secondary objectives of the trial

To assess the efficacy of four doses of BMS-663068 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 48 and at Week 96

To assess the safety of four doses of BMS-663068 in treatment-experienced HIV-infected subjects through Weeks 48 and 96 by measuring frequency of SAEs and AEs leading to discontinuations

To assess the immunologic activity of BMS-663068 based on change from baseline in CD4+ T-cell count at Weeks 24, 48, and 96

To assess the emergence of antiretroviral drug resistance in virus among subjects with virologic failure (VF) through Weeks 24, 48 and 96.

Evaluar la eficacia de cuatro dosis de BMS-663068 mediante la determinación de la proporción de sujetos con un ARN del VIH-1 en plasma < 50 copias/ml en las semanas 48 y 96.

Evaluar la seguridad de cuatro dosis de BMS-663068 en sujetos infectados por el VIH-1 tratados previamente hasta las semanas 48 y 96 mediante la medición de la frecuencia de AAG y AA que motiven la suspensión del tratamiento.

Evaluar la actividad inmunológica de BMS-663068 basándose en la variación con respecto al período basal del recuento de linfocitos TCD4+ en las semanas 24, 48 y 96.

Evaluar la aparición de resistencia a antirretrovirales de los virus en los sujetos con fracaso virológico (FV) hasta las semanas 24, 48 y 96.

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

Monotherapy Substudy (Optional. Part of the main protocol):

To assess the antiviral activity of BMS-626529 following administration of selected doses of BMS-663068 administered orally to HIV-1-infected subjects for 7 days

To assess safety and tolerability of multiple doses of BMS-663068 in HIV-1-infected subjects

To assess the effect of BMS-626529 following multiple doses of BMS-663068 on CD4+ and CD8+ lymphocyte counts and percents.

Primary Study Stage 1 Week 2 Intensive PK (Optional. Part of the main protocol):

To determine PK profiles that are projected to produce a wide range of exposures that will allow for differentiation of safety and PD effects of different doses of BMS 663-068.

To assess the steady-state PK of BMS-626529 when co-administered with RAL in antiretroviral-experienced HIV-1-infected subjects

To explore PK/PD relationships between BMS-626529 PK exposure or PK exposure normalized to viral drug susceptibility and efficacy, and safety outcomes

Pharmacogenetic substudy (Optional. Submitted as amendment 1 to the original protocol):

To permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use
DNA obtained from the blood sample and health information collected from the main clinical trial, AI438011 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of HIV-1 infections. Samples from this study may also be used in conjunction
with pharmacogenetic research results from other clinical studies to accomplish this objective.

Subestudio de monoterapia (parte opcional del protocolo principal)

Evaluar la actividad antiviral de BMS-626529 tras la administración de las dosis seleccionadas de BMS-663068 por vía oral a sujetos infectados por el VIH-1 durante 7 días.

Evaluar la seguridad y la tolerabilidad de dosis múltiples de BMS-663068 en sujetos infectados por el VIH-1.

Evaluar el efecto de BMS-626529 tras la administración de dosis múltiples de BMS-663068 sobre los recuentos y porcentajes de linfocitos CD4+ y CD8+.

Estudio primario estadio 1 semana 2, farmacocinética intensiva (Parte opcional del protocolo principal):

Determinar los perfiles farmacocinéticos que están proyectados para la producción de un amplio rango de exposiciones que permitirán la diferenciación de los efectos de seguridad y farmacodinámicos de diferentes dosis de BMS 663-068

Evaluar la farmacocinética en estado de equilibrio de BMS-626529 cuando se administra conjuntamente con RAL en sujetos infectados por el VIH-1 tratados previamente con antiretrovirales

Investigar relaciones FC/FD entre la exposición FC a BMS-626529 o la exposición FC normalizada respecto a la sensibilidad viral al medicamento y variables de eficacia y seguridad.

Subestudio farmacogenético (Opcional, presentado como enmienda 1 al protocolo original):

Permitir la obtención y conservación de muestras de sangre para uso en futuras investigaciones farmacogenéticas exploratorias. Bristol-Myers Squibb utilizará el ADN obtenido de las muestras de sangre y la información sanitaria recogida en el ensayo clínico principal, AI438011, para estudiar la asociación entre variaciones genéticas y respuesta a medicamentos. Bristol-Myers Squibb también podrá emplear el ADN para estudiar las causas y la progresión ulterior de la infección por el VIH-1. Las muestras de este estudio también podrán utilizarse junto con los resultados de investigación farmacogenética obtenidos en otros estudios clínicos para alcanzar este objetivo.

E.3

Principal inclusion criteria

Key inclusion criteria:

Plasma HIV-1 RNA ? 1000 copies/ml

Men and women

At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)

Antiretroviral treatment-experienced as defined in this protocol

Susceptibility to study drugs by genotype/phenotype/PhenoSense® Entry (AI)

CD4+ T-cell count > 50 cells/mm3

Criterios de inclusión fundamentales:

ARN del VIH-1 en plasma ? 1.000 copias/ml.

Varones y mujeres.

Al menos 18 años de edad (o edad mínima según lo determinado por los organismos reguladores locales o conforme a lo que dictaminen los requisitos legales, lo que sea mayor).

Tratamiento previo con antirretrovirales tal como se define en este protocolo.

Sensibilidad a los medicamentos del estudio según el genotipo/fenotipo/PhenoSense® Entry (IF).

Recuento de linfocitos T CD4+ > 50 células/mm3.

E.4

Principal exclusion criteria

Key exclusion criteria:

Chronic HBV/HCV infection

Contraindications to any of study drugs

History of resistance to any component of the study regimen (TDF, ATV, RAL)

Criterios de exclusión fundamentales:

Infección crónica por el VHB/VHC.

Contraindicaciones a cualquiera de los medicamentos del estudio.

Antecedentes de resistencia a cualquier componente del régimen del estudio (TDF, ATV, RAL).

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24;

Frequency of SAEs and discontinuations due to AEs through Week 24.

Proporción de sujetos con ARN del VIH-1 en plasma < 50 c/mL en la semana 24

Frecuencia de acontecimientos adversos graves y acontecimientos adversos que motiven la suspensión del tratamiento hasta la semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 24

E.5.2

Secondary end point(s)

Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Weeks 48 and 96;

Frequency of SAEs and discontinuations due to AEs through Weeks 48 and 96;

Changes from baseline in CD4+ T-cell count at Weeks 24, 48 and 96;

Frequency of newly-emergent genotypic substitutions and IC50 fold changes from baseline among subjects with virologic failure through Weeks 24, 48 and 96.

Proporción de sujetos con ARN del VIH-1 en plasma < 50 c/mL en las semanas 48 y 96;

Frecuencia de acontecimientos adversos graves y acontecimientos adversos que motiven la suspensión del tratamiento hasta las semanas 48 y 96

Cambios respecto al nivel basal en el recuento de células T CD4+ en las semanas 24, 48 y 96

Frecuencia de sustituciones genotípicas nuevas emergentes y cambios en la IC50 respecto al nivel basal entre los sujetos con fallo virológico en las semanas 24, 48 y 96

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 24, 48 and 96

Semanas 24, 48 y 96

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

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

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

parcialmente ciego

partially blinded

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

Germany

Romania

Spain

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

LVLS

Ultima visita del último sujeto

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:

250

F.1.3

Elderly (>=65 years)

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

F.4.2.2

In the whole clinical trial

250

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)

Study drug will be provided via a an extension study, rollover study or through another mechanism at the discretion of the sponsor. Access to study drug will be terminated if any of the following occur: a) the marketing application is rejected by responsible health authority; b) the study is terminated due to
safety concerns; c) the subject can obtain medication from a government sponsored or
private health program; or d) therapeutic alternatives become available in the localmarket.

Medicación estudio estará disponible a través de estudio de extensión, estudio rollover o a través de otro
mecanismo a discreción promotor. Acceso a medicación estudio terminará si: a) la solicitud
autorización comercialización es rechazada por la autoridad sanitaria; b) estudio se cancela por aspectos
seguridad; c) sujeto puede obtener la medicación a través de programa promocionado por gobierno o
por institución privada; o d) si en mercado local aparecen alternativas terapéuticas

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-12

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