Clinical Trials Register

Summary
EudraCT Number:	2014-000828-24
Sponsor's Protocol Code Number:	ANRS163ETRAL
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:	2015-06-01
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

2014-000828-24

A.3

Full title of the trial

A non-comparative phase II trial evaluating the capacity of the dual combination raltegravir/etravirine to maintain virological success in HIV-1 infected patients of at least 45 years of age with an HIV-RNA plasma viremia below 50 copies/mL
under a current boosted protease inhibitor containing regimen.

Ensayo clínico no-comparativo fase II para evaluar la capacidad de la combinación dual raltegravir/etravirina para mantener la supresión virológica en pacientes infectados por el VIH-1 de al menos 45 años de edad con una carga viral plasmática VIH-RNA por debajo de 50 copias/mL en tratamiento con un régimen que incluya un inhibidor de la proteasa potenciado.

A.3.1

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

ANRS 163 ETRAL

A.3.2

Name or abbreviated title of the trial where available

ETRAL

A.4.1

Sponsor's protocol code number

ANRS163ETRAL

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	Inserm-ANRS
B.1.3.4	Country	France
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	Merck Sharp Dohme
B.4.2	Country	France
B.4.1	Name of organisation providing support	Janssen Pharmaceutica NV
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Inserm-ANRS
B.5.2	Functional name of contact point	Anne-Laure ARGOUD
B.5.3	Address:
B.5.3.1	Street Address	101 rue de Tolbiac
B.5.3.2	Town/ city	PARIS
B.5.3.3	Post code	75013
B.5.3.4	Country	France
B.5.4	Telephone number	349322754003310
B.5.5	Fax number	33153946002
B.5.6	E-mail	anne-laure.argoud@anrs.fr

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	ISENTRESS
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ISENTRESS
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	RALTEGRAVIR
D.3.9.1	CAS number	518048-05-0
D.3.9.4	EV Substance Code	SUB25667
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	Yes
D.2.1.1.1	Trade name	INTELENCE
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Pharmaceutica NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	INTELENCE
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	ETRAVIRINE
D.3.9.1	CAS number	269055-15-4
D.3.9.4	EV Substance Code	SUB25650
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	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

HIV infection

Infección por el VIH

E.1.1.1

Medical condition in easily understood language

HIV infection

Infección por el 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	18.0
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 evaluate over 48 weeks of treatment the capacity to maintain virological success defined as the absence of 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen in HIV-1 infected patients, of at least 45 years of age, with suppressed plasma viremia switching from a boosted PI-containing regimen.

Evaluar a las 48 semanas de tratamiento la capacidad para mantener la supresión virológica, definida como la ausencia de 2 determinaciones consecutivas de carga viral plasmática (CV) > 50 copias/mL entre 2 y 4 semanas, de la combinación dual raltegravir/etravirina en pacientes infectados por el VIH-1 de al menos 45 años de edad y en supresión virológica que cambian desde un régimen que incluya un inhibidor de la proteasa potenciado.

E.2.2

Secondary objectives of the trial

Biological efficacy
- To assess the proportion of patients in therapeutic success up to week 48 and week 96.
-To assess the proportion of patients with virological success (plasma HIV-RNA ? 50 copies/mL) up to week 96.
-To assess the proportion of patients with an interruption of therapeutic strategy.
- To assess the proportion of patients with low grade virological failure (HIV-RNA plasma VL between 51 and 200 copies/mL) and the proportion of patients with high grade of virological failure defined as HIV-RNA > 200 copies/mL at time of virological failure.
Tolerability and Metabolic Impact
- Incidence of clinical and biological adverse effects.
- Incidence of clinical and biological adverse events (grade 3 or 4).
- Modification of metabolic parameters (fasting triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol and glycaemia).

Eficacia biológica
- Evaluar la proporción de pacientes con éxito terapéutico a las S 48 y 96
- Evaluar la proporción de pacientes con éxito virológico (VIH-RNA plasmático ? 50 copias/mL)
a la S96
- Evaluar la proporción de pacientes que interrumpen la estrategia terapéutica
- Evaluar la proporción de pacientes con fracaso virológico de bajo grado (VIH-RNA plasmático entre 51 y 200 copias/mL) y la proporción de pacientes con una alto grado de fracaso virológico definido como VIH-RNA > 200 copias/mL en el momento del fracaso virológico
Tolerabilidad e impacto metabólico
- Incidencia de acontecimientos adversos clínicos y biológicos
- Incidencia de acontecimientos adversos clínicos y biológicos de grado 3 o 4
- Cambios en parámetros metabólicos (triglicéridos, colesterol total, colesterol-HDL, colesterol-LDL y glicemia).

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

DXA-scan
After signing a sub-study-specific informed consent form, 80 patients will be included in the DXA-scan sub-study assessing the evolution of bone mineral density (BMD) and of the body fat distribution, and evaluating the potential impact of the dual raltegravir/etravirine regimen on these two parameters.
DXA-scans will be performed locally in all participating sites at D0, W48 and W96. The acquired images will be electronically transferred to a central review facility for final evaluation.

Subestudio de DEXA: el objetivo es evaluar los cambios en la distribución del tejido adiposo en la densidad mineral ósea y la distribución corporal. Este subestudio se llevará a cabo durante las vistas del día 0, y semanas 48 y 96. En él participarán 80 pacientes.

E.3

Principal inclusion criteria

- Documented HIV-1 infection.
- Age ? 45 years.
- Naïve to integrase inhibitor and etravirine.
- At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs.
- HIV-RNA plasma VL ? 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL.
- HIV-RNA plasma VL ? 50 copies/mL at screening visit (W-4).
- Absence of any documented NNRTI (Non-Nucleosidic Reverse Transcriptase Inhibitor) mutation other than K103N at any time in medical history.
- Full sensitivity of ETR in HIV DNA genotypic resistance test.
- CD4+ lymphocytes > 200 cells/mm3.
- Creatinine < 2.5 x ULN.
- CPK (Creatine Phospho Kinase) < 6 ULN.
- AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) < 5 ULN.
- Hemoglobin > 10 g/dL.
- Platelets > 100 000/mm3.
- Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential.
- For French participants only: patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
- Patients with a coverage from a social health.
- Signed informed consent.

- Infección por el VIH-1 documentada
- Edad ? 45 años
- No haber recibido previamente inhibidores de la integrasa y etravirina
- En tratamiento antirretroviral estable durante al menos 6 meses con un régimen que incluya un inhibidor de la proteasa potenciado, sea cual sea el número de fármacos de la combinación
- Carga viral plasmática VIH-RNA ? 50 copias/mL durante al menos los 24 mese previos a la visita de pre-selección (semanas -4) , documentadas al menos en 4 puntos con no más de un blip en la carga viral plasmática VIH-RNA entre 51 y 200 copias/mL
- Carga viral plasmática VIH-RNA ? 50 copias/mL en el momento de la visita de pre-selección (semana -4)
- Ausencia de cualquier mutación documentada a NNRTI distinta a K103N en cualquier momento de la historia de tratamiento
- Sensibilidad a etravirina según test de resistencia genotípica en VIH DNA
- Cifra de células CD4 > 200 células/mm3
- Creatinina < 2,5 x LSN
- CPK < 6 x LSN
- GOT, GPT < 5 x LSN
- Hemoglobina > 10 g/dL
- Plaquetas > 100.000/mm3
- Test de embarazo negative en orina y uso de medidas de contracepción en mujeres en edad fértil
- Pacientes con cobertura de la Seguridad Social
- Consentimiento informado firmado

E.4

Principal exclusion criteria

- Previous exposure to raltegravir or etravirine.
- Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac.
- HIV-2 infection.
- Active viral hepatitis C requiring a specific treatment during the 24 months of the trial.
- Patient with a history of non-compliance or irregular follow-up.
- Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or anti-diabetic treatment within the last 3 months prior the screening visit (W-4).
- Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John?s wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra?), Triazolam (Halcion®).
- Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy.
- Concomitant prophylactic or curative treatment for an opportunistic infection.
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance.
- Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
- Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
- Pregnant women or breastfeeding women.

- Exposición previa a raltegravir o etravirina
- Hepatitis B HBsAg positivo o HBc AC positivo y HBs Ac negativo
- Infección por el VIH-2
- Hepatitis C activa que requiera de tratamiento específico durante el estudio
- Pacientes con historia de no adherencia o seguimiento irregular
- Inicio de tratamiento concomitante para hipercolesterolemia (ej. Estatinas) o tratamiento con antidiabéticos durante al menos los 3 meses previos a la vista de pre-selección (semana -4)
- Pacientes en tratamiento con: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidina (Ticlid®), Flurbiprofeno (Antadys® - Cebutid®), Rifampicina (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentina (Priftin®), hierbas de San Juan, Carbamazepina (Tegretol®), Fenobarbital, Fenitoina (Dilantin®), Avanafilo (Stendra?) y Triazolam (Halcion®).
- Tratamiento concomitante con interferón, interleukina o cualquier fármaco inmunosupresor o quimioterapia
- Tratamiento concomitante profiláctico o curativo para infecciones oportunistas
- Cualquier condición (abuso de alcohol, drogas, etc.) que a juicio del investigador pueda interferir en el cumplimiento del protocolo, adherencia y/o tolerancia al tratamiento de la medicación en estudio
- Pacientes sin "capacidad legal" (pacientes sin capacidad legal para emitir su decisión libre de participar en el estudio debido a pérdida temporal y leve de facultades mentales o físicas), o bajo tutela legal
- Pacientes participando en otros ensayos clínicos que evalúen diferentes terapias y que incluyan un periodo de exclusión que vigente durante la fase de pre-selección
- Mujeres embarazadas o en periodo de lactancia

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients remaining, at week 48 on virological success defined as the absence of 2 consecutive HIV-RNA plasma VL > 50 copies/mL within 2 to 4 weeks interval.

Proporción de pacientes con éxito virológico a las 48 semanas, definida como ausencia de 2 determinaciones consecutivas de carga viral plasmática (CV) > 50 copias/mL entre un periodo de 2 y 4 semanas

E.5.1.1

Timepoint(s) of evaluation of this end point

W48

Semana 48

E.5.2

Secondary end point(s)

Biological efficacy
- Percentage of patients remaining in therapeutic success up to week 48 and week 96 defined as the absence of virological failure and the absence of treatment interruption due to adverse event judged by DSMB as related to the trial treatment or procedure.
- Percentage of patients in virological success (plasma HIV-RNA ? 50 copies/mL) up to week 96.
- Percentage of patients with trial treatment interruption.
- Percentage of patients with plasma HIV-RNA VL between 51 and 200 copies/mL) and percentage of patients with plasma HIVRNA VL > 200 copies/mL at time of virological failure.
- Median time of virological failure (time limit between the date of the trial treatment initiation and the date of virological failure).
- Percentage of patients with RAL and/or ETR resistance mutations in case of virological failure and percentage of patients with resistant viruses to all studydrug's class in case of virological failure.
- Factors associated with the occurrence of plasma HIV-RNA VL> 50 copies/mL (genotype history, pre-cART VL, plasma drug concentration (etravirine, raltegravir) at the virological rebound, viral reservoir measured by HIV-DNA at pre-inclusion and observance assessed with a self-questionnaire).
- Evolution of total cell-associated HIV-DNA from D0 to W48 and W96.
- Evolution of CD4+, CD8+ T cells counts and CD4/CD8 ratio at each time point from D0.

Tolerability and Metabolic Impact
- Percentage of patients with at least one serious adverse event as judged by DSMB as related to the trial treatment or to the trial strategy.
- Percentage of patients with grade 3 or grade 4 clinical or biological adverse events.
- Evolution of metabolic parameters (fasting triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol and fasting glycemia).
- Evolution of the calibrated Framingham risk score and of the SCORE risk equation including HDL cholesterol (from the European Cardiovascular Society) from D0 to W48 and W96.
- Evolution of renal function measured using proteinuria and the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula to estimate the Glomerular Filtration Rate (GFR) from D0 to W96.
- Evolution of limb lean, limb fat, visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT), measured by DXA scan (Dual-energy X-Ray Absorptiometry), from D0 to W48 and W96 (DXA scan sub-study, 80 patients).
- Evolution of bone mineral density measured by DXA scans from D0, to W48 and W96 (DXA scan sub-study, 80 patients).
- HIV-RNA viral load and Cmin (Residual Drug Concentration) of raltegravir and etravirine in seminal fluid at W48 (seminal sub-study, 20 patients).
- Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots from D0 to W48, and W96.
- Evaluation of health-related quality of life with a self-assessment questionnaire from D0 to W48, and W96 and of the compliance with a self-assessment questionnaire at W-4, W48, and W96.

Eficacia biológica
- Porcentaje de pacientes con éxito terapéutico a las 48 y 96 semanas, definido como la ausencia de fracaso virológico y la ausencia de interrupción de tratamiento debido a acontecimientos adversos que según el DSMB estén relacionados con el tratamiento o procedimiento del estudio
- Porcentaje de pacientes con éxito virológico (VIH-RNA plasmático? 50 copias/mL) a las 96 semanas
- Porcentaje de pacientes que interrumpen la estrategia terapéutica
- Porcentaje de pacientes con carga viral VIH-RNA 51 y 200 copias/mL y porcentaje de pacientes con carga viral VIH-RNA > 200 copias/mL en el momento del fracaso virológico
- Tiempo medio de fracaso virológico (tiempo entre la fecha de inicio de la medicación en estudio y la fecha del fracaso virológico)
- Porcentaje de pacientes con resistencias a raltegravir y/o etravirina en caso de fracaso virológico y pacientes con virus resistente a la familia del medicamento en estudio en caso de fracaso virológico
- Factores asociados con la ocurrencia de carga viral plasmático VIH-RNA > 50 copias/mL (historia genotipado, carga viral pre-tratamiento antirretroviral, concentración plasmática de fármaco (etravirina, raltegravir) y rebote virológico, reservorio viral medido mediante VIH-DNA en el momento basal y adherencia medida mediante cuestionario
- Cambios en las células totales asociadas al VIH-DNA desde la basal hasta la semana 48 y 96
- Cambios en la cifra de células de CD4, CD8 y ratio CD4/CD8 en cada visita desde el momento basal

Tolerabilidad e impacto metabólico
- Porcentaje de pacientes con al menos un acontecimiento adverso grave que según el DSMB esté relacionado con el tratamiento o la estrategia del estudio
- Porcentaje de pacientes con acontecimientos adversos clínicos y biológicos de grado 3 o 4
- Cambios en parámetros metabólicos (triglicéridos, colesterol total, colesterol-HDL, colesterol-LDL y glicemia).
- Cambios en el cálculo de riesgo cardiovascular de Framingham y SCORE (según Sociedad Europea Cardiovascular) (http://www.escardio.org/communities/EACPR/toolbox/health-professionals/Pages/SCORE-Risk-Charts.aspx), desde el momento basal hasta las semanas 48 y 96
- Cambios en la función renal evaluada mediante proteinuria y la fórmula CKD-EPI para estimar la tasa de filtrado glomerular (TFG) desde el momento basal hasta la semana 96
- Cambios en la distribución de la grasa periférica y visceral medida mediante DEXA desde el momento basal hasta las semanas 48 y 96 (subestudio DEXA, 80 pacientes)
- Cambios en la distribución de la masa magra en extremidades y tejido adiposo visceral y tejido adiposo subcutáneo medido mediante DEXA desde el momento basal hasta las semanas 48 y 96 (subestudio DEXA, 80 pacientes)
- Cambios en la densidad mineral ósea medida mediante DEXA desde el momento basal hasta las semanas 48 y 96 (subestudio DEXA, 80 pacientes)
- Cambios en biomarcadores inflamatorios (IL-6hs, sCD14, sCD163, D-Dimeros, IP-10, IgG, CRPus e insulina) en alícuotas de plasma congeladas en la visita basal y en las visitas de las semanas 48 y 96
- Evaluación del cuestionario de calidad de vida en la visita basal y en las semanas 48 y 96 y, del cuestionario de adherencia durante las semanas -4, 48 y 96

E.5.2.1

Timepoint(s) of evaluation of this end point

W48 and W96

Semanas 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

Yes

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)

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

6 months after the last visit of the last patient

6 meses tras la última 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

E.8.9.2

In all countries concerned by the trial years

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

160

F.4.2.2

In the whole clinical trial

160

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)

At the end of the trial, for each participant, according to the trial results, the investigator will decide to maintain or change the trial treatment. The patients will be followed with the best clinical practices.

Si los resultados finales son concluyentes, el investigador podrá considerar la continuidad del tratamiento

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

2015-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-27

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