Clinical Trials Register

Summary
EudraCT Number:	2012-003595-39
Sponsor's Protocol Code Number:	APACHE
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-11-29
Trial 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

2012-003595-39

A.3

Full title of the trial

A randomized, pilot clinical trial designed to compare, in human immunodeficiency virus infected patients who never have received antiretroviral therapy, the evolution of cerebral function and the neurocognitive efficient after 24 weeks of treatment with 2 regimens of highly efficacy antiretroviral treatment with different levels of central nervous system penetration.

Ensayo clínico, randomizado, piloto, diseñado para comparar, en sujetos infectados por el virus de la inmunodeficiencia humana que nunca han recibido tratamiento antorretroviral, la evolucion del funcionamiento cerebral y del rendimiento neurocognitivo tras 24 semanas de tratamiento con dos regimenes de tratamiento antirretroviral de gran eficacia con distintos niveles de penetración en el sistema nerviosos central.

A.3.1

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

A clinical trial to compare brain function and neurocognitive performance in antiretroviral treatments with different levels of penetration in the central nervous system.

Ensayo clínico para comparar el funcionamiento cerebral y rendimiento neurocognitivo en tratamientos antirretrovirales con distintos niveles de penetracion en el sistema nervioso central.

A.3.2

Name or abbreviated title of the trial where available

Apache

A.4.1

Sponsor's protocol code number

APACHE

A.5.4

Other Identifiers

Name:

Eudra CT

Number:

2012-003595-39

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	Fundación para la Investigación Biomédica del Hospital Universitario La Paz
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundacion para la Investigacion Biomédica del Hospital Universitario La Paz
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FIBHULP
B.5.2	Functional name of contact point	Maria Yllescas
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la Castella 261
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917277558
B.5.5	Fax number	0034912071876
B.5.6	E-mail	maria.yllescas@idipaz.es

D. IMP Identification
D.IMP: 1
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	Reyataz
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB PHARMA EEIG
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.3.1	Product name	ATAZANAVIR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Atazanavir sulfato
D.3.9.3	Other descriptive name	ATAZANAVIR SULFATE
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: 2
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	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	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.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	Kivexa
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare UK 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	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	ABACAVIR SULFATE
D.3.9.1	CAS number	188062-50-2
D.3.9.3	Other descriptive name	ABACAVIR SULFATE
D.3.9.4	EV Substance Code	SUB00231MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LAMIVUDINE
D.3.9.1	CAS number	134678-17-4
D.3.9.4	EV Substance Code	SUB08392MIG
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	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	Sustiva
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
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	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	EFAVIRENZ
D.3.9.1	CAS number	154598-52-4
D.3.9.4	EV Substance Code	SUB06463MIG
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: 5
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	Truvada
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences International 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	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	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.4	EV Substance Code	SUB01882MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR DISOPROXIL
D.3.9.1	CAS number	147127-20-6
D.3.9.4	EV Substance Code	SUB20643
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	245
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients infected with human immunodeficiency virus who have never received antiretroviral treatment.

Pacientes infectados con virus de inmunodeficiencia humana que nunca han recibido tratamiento antirretroviral.

E.1.1.1

Medical condition in easily understood language

HIV

VIH

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Changes in the levels of N-acetyl-aspartate (NAA) in the basal brain ganglia

Variación de los niveles de N-Acetil-Aspartato (NAA) en los ganglios basales cerebrales

E.2.2

Secondary objectives of the trial

- Change in neurocognitive functioning
- Changes in the levels of NAA in the frontal lobe
- Changes in the levels of choline, myoinositol and glutamate in the basal ganglia and frontal lobe
- Change in the volume of brain structures
- Changes in the white matter abnormalities
- Virologic failure
- Therapeutic failure
- Changes in the levels of CD4
- Adherence to HAART
- Adverse effects

- Variación del funcionamiento neurocognitivo
- Variación de los niveles de NAA en el lóbulo frontal
- Variación de los niveles de Colina, mioinositol y glutamato en los ganglios basales y el lóbulo frontal
- Variación del volumen de las estructuras cerebrales
- Variación de las anomalías de la sustancia blanca
- Fallo virológico
- Fallo terapeútico
- Variación de los niveles de CD4
- Adherencia al TARGA
- Efectos adversos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- HIV-positive by ELISA and confirmed by WB
- Age> 18 years
- Never have received antiretroviral treatment for HIV
- CV baseline of HIV> 100,000 copies / mL
- No evidence of genotypic resistance against antiretroviral
- Study HLA B5701 negative
- Having a VL <100,000 copies / mL
- Able to understand and give written informed consent.
- Meet the criteria to initiate the AR treatment according to Gesida 2012 Guideline.
-Women of childbearing potential should have a pregnancy test negative in blood or urine during the 7 days prior to initiation of therapy and postmenopausal women should have amenorrhea for at least 12 months to consider that they are of childbearing age.
- Non pregnant or lactating without heterosexual activity during the entire study or heterosexual activity and willing to use two methosds of contraception. The two methods of contraception can be 2 barrier methods or a barrier method and a method to prevent pregnancy hormone, used during the entire study and for 12 weeks after completion.

-VIH positivo mediante ELISA y confirmado mediante WB
- Edad > 18 años
- No haber recibido nunca tratamiento antiretroviral frente al VIH
- CV basal de VIH > 100.000 copias/mL
- Ausencia de evidencia de resistencias genotípicas frente a antiretrovirales
- Estudio HLA B5701 negativo
- Tener una CV < 100.000 copias/mL
- Capaz de entender y dar su consentimiento informado por escrito.
- Cumplir criterios para el inicio del tratamiento antirretroviral de acuerdo con las recomendaciones recogidas en las guías de GESIDA 2012.
- Las mujeres en edad fértil deberán tener una prueba de embarazo en sangre o en orina negativa durante los 7 días anteriores al Inicio del tratamiento y las mujeres posmenopáusicas deben presentar amenorrea desde hace al menos 12 meses para considerar que no están en edad fértil.
- Puede incluirse a mujeres no embarazadas ni lactantes sin actividad heterosexual durante la totalidad del estudio O con actividad heterosexual y dispuestas a utilizar 2 métodos anticonceptivos. Los 2 métodos anticonceptivos pueden ser 2 métodos de barrera 0 un método de barrera y un método hormonal para prevenir el embarazo, utilizados durante la totalidad del estudio y hasta 12 semanas tras la finalización del mismo.

E.4

Principal exclusion criteria

1. Pregnant or lactating women and women of childbearing age who are not committed to use adequate contraception method.
2. Previous history of serious confounding neurological comorbidities defined as:
- Dependence on drugs or alcohol
- CNS opportunistic infections
- Major depression or psychosis
- Previous diagnosis of dementia
- Mental retardation
- CNS neurological disease
- Co-infection with hepatitis C virus
3. Claustrophobia
4. Existence of magnetizable body devices
5. Inability to perform and complete a full neurologic assessment
6. Renal insufficiency (creatinine clearance <60 mL / min)
7. Diabetes mellitus or cardiovascular risk> 10% calculated by Framingham
8. The following analytical criteria:
- Neutropenia <750 cells / ?L
- Hemoglobin <8.0 g / dL
- Platelets <50,000 cells / ?L
- Levels of GOT, GPT and GGT greater than 5 times the baseline levels

1. Mujeres embarazadas o lactantes, así como mujeres en edad fértil que no se comprometan a utilizar un método anticonceptivo adecuado2. Historia previa de comorbilidades neurológicas de confusión graves definidas como:
- Dependencia de drogas o alcohol
- Infecciones oportunistas del SNC
- Depresión mayor o psicosis
- Diagnóstico previo de demencia
- Retraso mental
- Enfermedad neurológica del SNC
- Coinfección por el virus de la hepatitis C
3. Claustrofobia
4. Existencia de dispositivos corporales magnetizables
5. Inhabilidad para realizar y completar una evaluación neurológica completa
6. Presencia de insuficiencia renal (Aclaramiento de creatinina <60 mL/min)
7. Diabetes mellitus o un riesgo cardiovascular > 10% calculado por Framingham
8. Los siguientes criterios analíticos:
- Neutropenia < 750 células/?L
- Hemoglobina < 8,0 g/dL
- Plaquetas < 50.000 células/?L
- Niveles de GOT, GPT o GGT superiores a 5 veces los niveles de referencia

E.5 End points

E.5.1

Primary end point(s)

Variation of NAA levels in the cerebral basal ganglia, measured by NMR spectroscopy between two different HAART regimens with different penetration in the CNS

Variación de los niveles de NAA en los ganglios basales cerebrales, medidos mediante RMN con espectroscopia entre dos regímenes de TARGA con distinta penetración en el SNC

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to week 24

Desde la visita basal hasta la semana 24

E.5.2

Secondary end point(s)

1-Variation of the "Global Defict Score" (GDS)
2-Variation of NAA levels in the structures of the frontal cortex as measured by NMR spectroscopy
3-Glutamate and choline levels in the basal ganglia structures and frontal cortex as measured by NMR spectroscopy
4-Evolution of brain volumes measured by MRI volumetry
5-White matter abnormalities on MRI measured by MRI, by anisotropy
6-HIV-CV> 50 copies / mL. Development of resistance mutations to any of the antiretrovirals used
7-Modification of HAART for another with different CNS penetration (exchange of CPE Score> ± 1); presence of virological failure, loss or removal of the monitoring from the study for any reason
8-Variation in the absolute levels of CD4 +
9-Levels of adherence to HAART, as measured by adherence questionnaire GEMMA
10-Number of general and specific adverse effects of CNS related and unrelated to HAART, and cumulative incidence of them

1-Variación del "Global Defict Score" (GDS)
2-Variación de los niveles de NAA en las estructuras de la corteza frontal, medidos mediante RMN con espectroscopia
3-Niveles de colina y glutamato en las estructuras de los ganglios basales y la corteza frontal, medidos mediante RMN con espectroscopia
4-Evolución de los volúmenes cerebrales medidos mediante volumetría por RMN
5-Anomalías en la sustancia blanca medidas por RMN, mediante anisotropía
6-CV de VIH > 50 copias/mL. Desarrollo de mutaciones de resistencia a alguno de los antiretrovirales utilizados
7-Modificación del TARGA por otro con distinta penetración en el SNC (cambio del CPE Score > ± 1); presencia de fallo virológico; pérdida de seguimiento o retirada del estudio por cualquier razón
8-Variación de los niveles absolutos de linfocitos CD4+
9-Niveles de adherencia al TARGA, medidos por el cuestionario de adherencia GEMMA
10-Número de efectos adversos generales y específicos del SNC relacionados y no relacionados con el TARGA; incidencia acumulada de los mismos

E.5.2.1

Timepoint(s) of evaluation of this end point

1-From baseline to week 24
2-From baseline to week 24
3-From baseline to week 24
4-From baseline to week 24
5-From baseline to week 24
6-From baseline to week 24
7-From baseline to week 24
8-From baseline to week 24
9-Baseline and weeks 4, 12 and 24
10-Baseline and weeks 4, 12 and 24

1-Desde la visita basal hasta el la semana 24
2-Desde la visita basal hasta el la semana 24
3-Desde la visita basal hasta el la semana 24
4-Desde la visita basal hasta el la semana 24
5-Desde la visita basal hasta el la semana 24
6-Desde la visita basal hasta el la semana 24
7-Desde la visita basal hasta el la semana 24
8-Desde la visita basal hasta el la semana 24
9-Visitas basal y semanas 4, 12 y 24
10-Visitas basal y semanas 4, 12 y 24

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

LPLV

Ultima visita del último paciente

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

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:

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

F.3.3.1

Women of childbearing potential not using contraception

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.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)

Treatment according to standard of care

Tratameiento según la práctica clínica habitual

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

2013-02-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-21

P. End of Trial
P.	End of Trial Status	Ongoing

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