Clinical Trials Register

Summary
EudraCT Number:	2005-004330-40
Sponsor's Protocol Code Number:	1100.1470
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:	2012-03-29
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

2005-004330-40

A.3

Full title of the trial

Ensayo clínico abierto y randomizado, para comparar la seguridad y eficacia virológica de Atazanavir/ritonavir versus Nevirapina con un régimen de base que incluya Tenofovir y Emtricitabina, en pacientes infectados por VIH 1 que no han recibido tratamiento antirretroviral previo

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

ARTEN

A.4.1

Sponsor's protocol code number

1100.1470

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	Boehringer Ingelheim España, S.A.
B.1.3.4	Country	Spain
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	Boehringer Ingelheim España, S.A.
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	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+1-800-243-0127
B.5.5	Fax number	+1-800-821-7119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	Yes
D.2.1.1.1	Trade name	Viramune 200 mg comprimidos
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
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	Viramune
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	NEVIRAPINE
D.3.9.1	CAS number	129618402
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.3.11 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	REYATAZ 150 mg capsulas duras
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	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	Reyataz
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
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: 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	Norvir 100 mg capsulas blandas
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.3.1	Product name	Norvir
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	155213675
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	Truvada film-coated tablets.
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	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	Truvada
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	emtricitabine and tenofovir disoproxil
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	200 to 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.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

Este ensayo abierto, randomizado y controlado se realizará en pacientes infectados por VIH 1 que no hayan recibido tratamiento antirretroviral previo (durante más de 7 días en total).

E.1.1.1

Medical condition in easily understood language

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	14.1
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

El objetivo principal de este ensayo clínico es comparar la seguridad y eficacia de atazanavir potenciado con RTV con nevirapina en dos pautas de administración diferentes, añadiendo a cada grupo emtricitabina y tenofovir DF como régimen de base.

E.2.2

Secondary objectives of the trial

? Cambio respecto a la situación basal en los niveles plasmáticos en ayunas de colesterol total y sus fracciones (HDLC y LDLC), de la relación CT/ HDLC, de la apolipoproteína A1 y B, de PCRas y de los niveles totales de triglicéridos al cabo de 48, 96 y 144 semanas de tratamiento.
? Cambio en la estimación del riesgo cardiovascular mediante al algoritmo de Framingham de los pacientes de todos los grupos de tratamiento al cabo de 48, 96 y 144 semanas de tratamiento.
? Cambio en la calidad de vida respecto a la situación basal después de 24, 48, 96 y 144 semanas.
? Coste efectividad de cada pauta de tratamiento en los períodos de tiempo transcurridos desde el momento basal hasta 24, 48, 96 y 144 semanas de tratamiento.

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

Sub estudio metabólico, ver la section 5.3.1 del protocolo: El subestudio metabólico se realizará en los siguientes países: Australia, Canadá, Italia, México, Polonia, Rumanía, España y Estados Unidos.
Las variables de valoración del subestudio metabólico incluyen (para ver más detalles mirar la seción 5.3.2 del protocolo):
?Incidencia y gravedad de la lipodistrofia, lípidos en suero y anormalidades glicémicas
?Cambios en los perfiles de lipoproteínas obtenidos mediante RMN (tamaño y número de partículas de LDL, HDL, IDL y VLDL); niveles de insulina, adiponectina y leptina.

E.3

Principal inclusion criteria

1. Consentimiento informado firmado, de acuerdo con las Normas de Buena Práctica Clínica (BPC) y los requisitos regulatorios locales, obtenido antes de su participación en el ensayo
2. Hombres y mujeres ? 18 años de edad infectados por VIH 1 con una serología positiva (ELISA) confirmada por Western blot.
3. No haber recibido tratamiento antirretroviral previo (durante más de 7 días).
4. Hombres con cifras de CD4+ < 400 células/mm3 y mujeres con cifras de CD4+ < 250 células/mm3.
5. Susceptibilidad a NVP y ATZ/r basada en el resultado de un test de resistencia genotípica.
6. Función renal adecuada, definida como un aclaramiento de creatinina (CLCr) ? 50 ml/min calculado según la fórmula de Cockcroft Gault, que es:
Hombres: (140 edad en años) x (peso en kg) dividido por 72 x (creatinina sérica en mg/dl) = CLCr (ml/min).
Mujeres: (140 edad en años) x (peso en kg) dividido por 72 x (creatinina sérica en mg/dl) x 0,85 = CLCr (ml/min).
7. Índice de Karnofsky ? 70
8. Historia clínica aceptable, según criterio del investigador.

E.4

Principal exclusion criteria

1. Toxicomanía activa o alcoholismo crónico a juicio del investigador.
2. Cirrosis hepática en estadio Child Pugh B o C.
3. Mujeres en edad fértil que:
? Con una prueba de embarazo positiva en la visita de selección o durante el estudio.
? En periodo de lactancia,
? Que tengan intención de quedarse embarazadas,
? Que no se comprometan a utilizar un método anticonceptivo de barrera, o no deseen utilizar métodos anticonceptivos que no sean anticonceptivos orales que contengan etinil estradiol.
4. Parámetros de laboratorio > Grado 2 de la DAIDS (excepto triglicéridos > Grado 3 de la DAIDS, colesterol total sin restricciones
5. Hepatitis B o C activa definida como HBsAg positivo o ARN del VHC positivp con AST/ALT > 2.5 x LSN (> Grado 1 de la DAIDS).
6. Hipersensibilidad a cualquiera de los componentes de los productos en investigación.
7. Pacientes que reciban tratamiento con fármacos nefrotóxicos (como aminoglucósidos, anfotericina B, vancomicina, cidofovir, foscarnet, cisplatino, pentamidina, tacrolimus, ciclosporina) o competidores potenciales de la excreción renal (como cidofovir, aciclovir, valaciclovir, ganciclovir, valganciclovir, probenecid, antiinflamatorios no esteroideos en dosis altas (como ibuprofeno)) dentro de los 3 meses anteriores a la selección del estudio o durante el mismo.
8. Pacientes que estén recibiendo otros tratamientos concomitantes que no estén permitidos, según figuran en el Anexo 10.6.
9. Uso de otros medicamentos en fase de investigación clínica dentro de los 30 días anteriores al comienzo de la participación en el estudio o durante el mismo.
10. Uso de fármacos inmunomoduladores dentro de los 30 días anteriores al comienzo de la participación en el estudio o durante el mismo (como interferón, ciclosporina, hidroxiurea, interleukina 2, tratamiento crónico con prednisona).
11. Pacientes con leucoencefalopatía multifocal progresiva (LMP), sarcoma de Kaposi (SK) visceral y/o cualquier tipo de linfoma.
12. Cualquier enfermedad definitoria de SIDA que esté sin resolver, sea sintomática o sea inestable a pesar de tratamiento durante al menos 12 semanas antes de la visita de selección.
13. Pacientes que reciban tratamiento sistémico para enfermedades malignas.
14. Pacientes que en opinión del investigador no sean candidatos a ser incluidos en el estudio.

E.5 End points

E.5.1

Primary end point(s)

La variable principal de evaluación es la respuesta al tratamiento (RT) en la Semana 48. La RT se define como una carga viral < 50 copias/ml medida en dos visitas consecutivas antes de la Semana 48 y sin rebote o cambio posterior del tratamiento ARV antes de la Semana 48. Si la CV es ? 50 copias/ml en la Semana 48 y se trata del primer valor secuencial de la CV > 50 copias/ml después de una respuesta al tratamiento, será necesaria otra medición al menos 2 semanas después para determinar si se ha producido un rebote. Un rebote se define como dos mediciones consecutivas de la CV ? 50 copias/ml, al menos con dos semanas de diferencia, después de dos mediciones consecutivas de la CV < 50 copias/ml.
Un cambio de tratamiento ARV se define como:
? la discontinuación permanente del fármaco en estudio o su control;
? un cambio en la dosis de ATZ o RTV;
El cambio de NVP administrada una vez al día a NVP administrada dos veces al día, y viceversa, no se considera un fracaso en el análisis principal. Así pues, se considera que el paciente sigue respondiendo al tratamiento en este caso si se cumplen todos los demás criterios.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

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

Argentina

Germany

Italy

Mexico

Poland

Portugal

Romania

Spain

Switzerland

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

Ver la deficinión en el apratado 6.2.3 del protocolo:Se realizará una visita post ensayo a todos los pacientes que finalicen el ensayo o lo abandonen de forma prematura. La visita post ensayo define el final del ensayo propiamente dicho (salida del último paciente). Esta visita tiene que realizarse entre 28 y 35 días tras la visita fin de ensayo (EOT). En esta visita se evaluará la seguridad de NVP y ATZ/r, una vez finalizada la participación en el estudio.

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:

562

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-29.

Yes

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

115

F.4.2

For a multinational trial

F.4.2.1

In the EEA

269

F.4.2.2

In the whole clinical trial

561

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)

Ver apartado 6.2.3:
En la visita al EOT se interrumpirá el tratamiento con la medicación en investigación. Si el médico responsable lo considera conveniente, los pacientes mantendrán el tratamiento que se les haya asignado con suministros comerciales de los fármacos. De lo contrario, el médico responsable de su tratamiento les recomendará un nuevo tratamiento TARGA que sea más indicado para el tratamiento standar del paciente una vez finalizado el tratamientos con el fármaco en investigación.

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

2007-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-11-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-02-08

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IMP with orphan designation in the indication
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