Clinical Trials Register

Summary
EudraCT Number:	2014-002281-70
Sponsor's Protocol Code Number:	2014-002281-70
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:	2014-12-15
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

2014-002281-70

A.3

Full title of the trial

Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial).

Reconstitución inmune en pacientes con infección por el VIH-1 no tratados previamente y con cifras de linfocitos CD4+ inferiores a 100 céls/mm3 que reciben un régimen de fármacos antirretrovirales basado en dolutegravir o darunavir/ritonavir. Estudio AdvanZ-4.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ADVANZ-4

A.4.1

Sponsor's protocol code number

2014-002281-70

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	Fundació Clínic per a la Recerca Biomèdica
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	ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
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	CTU Clinic (Clinical Trial Unit)
B.5.2	Functional name of contact point	Anna Cruceta
B.5.3	Address:
B.5.3.1	Street Address	Rosello 138
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349322754004380
B.5.5	Fax number	+34932279877
B.5.6	E-mail	acruceta@clinic.ub.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	KIVEXA( Abacavir 600 mg/ Lamivudine 300 mg) recovered tablets
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.3.1	Product name	CoatedTablet600 mg de abacavir ( sulfate) 300 mg de lamivudine
D.3.4	Pharmaceutical form	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	ABACAVIR
D.3.9.1	CAS number	136470-78-5
D.3.9.4	EV Substance Code	SUB07356MIG
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	150
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	PREZISTA 300 mg recovered Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Bélgica
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	PREZISTA 300 mg comprimidos recubiertos con película darunavir
D.3.4	Pharmaceutical form	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	DARUNAVIR
D.3.9.1	CAS number	206361-99-1
D.3.9.4	EV Substance Code	SUB25394
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: 3
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 100 mg soft Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd Maidenhead SL6 4XE Reino Unido
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	Norvir 100 mg soft tablets
D.3.4	Pharmaceutical form	Capsule, soft
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: 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	TRIUMEQ®: Lamivudine(3TC) 300 mg+ Abacavir(ABC) 600 mg + dolutegravir(DGT) 50 mg : 1 comprimido
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Triumeq
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	LAMIVUDINE
D.3.9.1	CAS number	134678-17-4
D.3.9.2	Current sponsor code	ACH-126,443
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.3.8 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.3.9.2	Current sponsor code	GSK1349572
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	DOLUTEGRAVIR
D.3.9.1	CAS number	1051375-16-6
D.3.9.2	Current sponsor code	GSK1349572
D.3.9.3	Other descriptive name	DOLUTEGRAVIR
D.3.9.4	EV Substance Code	SUB35122
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)	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

tratement HIV infection

tratamiento de la infección por HIV

E.1.1.1

Medical condition in easily understood language

HIV infection

infección por HIV

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

-Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.

-Comparar el cambio en la cifra absoluta de CD4 en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.

E.2.2

Secondary objectives of the trial

-Compare the proportion of patients with undetectable viral load at 48 and 96 weeks.
-Compare the proportion of patients with CD4 above 200 celsmm3 to the
48 and 96 weeks of initiating treatment.
-Compare the change in the parameters of immune activation (especially in CD8 and CD8CD38 cells).
-Compare the change in the parameters of bacterial translocation (sCD14), inflammation (IL.6, TNF-alpha and ultrasensitive PCR) and coagulation (Dimer-D).
-To compare the changes in the intestinal Microbiome.
-Describe the proportion of patients who develop (SIRI) immune reconstitution syndrome.
-Describe the clinical tolerability and toxicity of the three guidelines.
-Describe the plasma lipid profile.
-Determine the pattern of mutations of resistance in cases of treatment failure.
-To compare the rate of progression of the disease and survival.

- Comparar la proporción de pacientes con carga viral indetectable a las 48 y 96 semanas.
- Comparar la proporción de pacientes con CD4+ por encima de 200 céls/mm3 a las
48 y 96 semanas de iniciar el tratamiento.
- Comparar el cambio en los parámetros de activación inmune (en especial en las células CD8+ y CD8+CD38+).
- Comparar el cambio en los parámetros de translocación bacteriana (sCD14), inflamación (IL.6, TNF-alfa y PCR ultrasensible) y coagulación (Dímero-D).
- Comparar los cambios en el microbioma intestinal.
- Describir la proporción de pacientes que desarrollan síndrome de reconstitución inmune (SIRI).
- Describir la tolerabilidad clínica y la toxicidad de las tres pautas.
- Describir el perfil lipídico plasmático.
- Determinar el patrón de mutaciones de resistencia en los casos de fracaso terapéutico.
- Comparar la tasa de progresión de la enfermedad y la supervivencia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. chronic infection by HIV-1.
2. equal to or more than 18 years old.
3 that you have not previously received anti-retroviral treatment.
4 digit baseline CD4 count 100 Celsµl (confirmed by two determinations).
5 result of baseline genotypic resistance study showing absence of mutations of resistance to drugs in the study.
6 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.

1. Infección crónica por VIH-1.
2. Edad igual o superior a 18 años.
3. Que no hayan recibido previamente tratamiento antirretroviral.
4. Cifra basal de CD4+ <100 céls/µL (confirmada por dos determinaciones).
5. Resultado del estudio de resistencias genotípicas basal que muestre ausencia de mutaciones de resistencia a los fármacos en estudio.
6. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta.

E.4

Principal exclusion criteria

Known hypersensitivity to drugs in the study.
2. hypersensitivity documented to sulfonamides and derivatives.
3 positivity in the determination of the HLA B5701.
4 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
5 lymphomas and other active Neoplasms that require chemotherapy.
6. less than 50 mlmin creatinine clearance.
7 liver failure moderate or severe (Child-Pugh classification C class).
8 ALT ?5 times the upper limit of normal (ULN), or ALT ?3 times the ULN and total bilirubin ?1, 5 times the ULN (with 35 of direct bilirubin).
9. need for treatment of HCV during the study.
10. current or recent treatment with nephrotoxic drugs.
11. treatment with immunomodulators, or products under investigation.
12. treatment with drugs or products whose pharmacokinetic interaction potential decrease efficiency or increase the toxicity of antiretroviral drugs in the study.
13. any formal contraindication to be treated with the drugs in the study.

1. Hipersensibilidad conocida a los medicamentos en estudio.
2. Hipersensibilidad documentada a sulfamidas y derivados.
3. Positividad en la determinación del HLA B5701.
4. Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio.
5. Linfomas y otras neoplasias activas que requieran quimioterapia.
6. Aclaramiento de creatinina inferior a 50 ml/min.
7. Insuficiencia hepática moderada o grave (Clase C de la clasificación de Child-Pugh).
8. ALT ?5 veces el límite superior de la normalidad (LSN) o ALT ?3 veces el LSN y bilirrubina total ?1,5 veces el LSN (con > 35% de bilirrubina directa).
9. Necesidad de tratamiento del VHC durante el estudio.
10. Tratamiento actual o reciente con fármacos nefrotóxicos.
11. Tratamiento con fármacos inmunomoduladores, o productos en fase de investigación.
12. Tratamiento con fármacos o productos cuyo potencial de interacción farmacocinética disminuya la eficacia o aumente la toxicidad de los antirretrovirales en estudio.
13. Cualquier contraindicación formal para ser tratado con los fármacos del estudio.

E.5 End points

E.5.1

Primary end point(s)

Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.

Comparar el cambio en la cifra absoluta de CD4+ en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Average increase in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.

Incremento medio en la cifra absoluta de CD4+ en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Proportion of patients presenting with undetectable viral load (50 copiasmL or ultrasensitive) after 48 and 96 weeks for inclusion in the study.

-Proportion of patients with CD4 above 200 celsmm3 to the 48 and 96 weeks of initiating treatment.
-Compare the change in cells CD8 and CD8CD38 48 and 96 weeks of initiating treatment.
-
-Proportion of patients with immune reconstitution syndrome.
-Incidence of clinical adverse events and laboratory abnormalities causing the withdrawal of treatment in study.
-Changes in triglycerides, total cholesterol and HDL and LDL cholesterol.
-Incidence and type of resistance mutations in patients presenting virologic failure.
-Rate of progression to AIDS and death.

Proporción de pacientes que presentan carga viral indetectable (<50 copias/mL o ultrasensible) al cabo de 48 y 96 semanas de la inclusión en el estudio.

- Proporción de pacientes con CD4+ por encima de 200 céls/mm3 a las 48 y 96 semanas de iniciar el tratamiento.
- Comparar el cambio en las células CD8+ y CD8+CD38+ a las 48 y 96 semanas de iniciar el tratamiento.
-
- Proporción de pacientes con síndrome de reconstitución inmune.
- Incidencia de acontecimientos adversos clínicos y alteraciones de laboratorio que provoquen la retirada del tratamiento en estudio.
- Cambios en los triglicéridos, colesterol total y colesterol HDL y LDL.
- Incidencia y tipo de mutaciones de resistencia en los pacientes que presenten fracaso virológico.
- Tasa de progresión a SIDA y de mortalidad.

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

Yes

E.6.4

Safety

E.6.5

Efficacy

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

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

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

LVLS

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:

108

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

108

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)

none

ninguna

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

2015-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-17

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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