Clinical Trials Register

Summary
EudraCT Number:	2013-001326-25
Sponsor's Protocol Code Number:	ACA-SPAI-11-24
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:	2013-06-10
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

2013-001326-25

A.3

Full title of the trial

Efficacy and safety of paricalcitol in the reduction of secondary hyperparathyroidism after renal transplantation.

Eficacia y seguridad del paricalcitol para la reducción del hiperparatiroidismo secundario después del trasplante renal.

A.3.1

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

Efficacy and safety of paricalcitol in the reduction of secondary hyperparathyroidism after kidney transplantation.

Eficacia y seguridad del paricalcitol para la reducción del hiperparatiroidismo secundario después del trasplante de riñón.

A.3.2

Name or abbreviated title of the trial where available

PARIDOINAL2013

A.4.1

Sponsor's protocol code number

ACA-SPAI-11-24

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 SENEFRO
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	ABBVIE Farmacéutica, S.L.U.
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	Hospital Universitari de Bellvitge
B.5.2	Functional name of contact point	Josep M Cruzado
B.5.3	Address:
B.5.3.1	Street Address	Calle Feixa Llarga s/n
B.5.3.2	Town/ city	LHospitalet de Llobregat / Barcelona
B.5.3.3	Post code	08907
B.5.3.4	Country	Spain
B.5.4	Telephone number	3493260 76 02
B.5.5	Fax number	3493260 76 07
B.5.6	E-mail	jmcruzado@bellvitgehospital.cat

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	Zemplar
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBVIE FARMACEUTICA, S.L.U
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	Zemplar
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	PARICALCITOL
D.3.9.1	CAS number	131918-61-1
D.3.9.3	Other descriptive name	PARICALCITOL
D.3.9.4	EV Substance Code	SUB09627MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Hidroferol
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES Farma S.A
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	Hidroferol
D.3.4	Pharmaceutical form	Oral drops
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	CALCIFEDIOL
D.3.9.1	CAS number	19356-17-3
D.3.9.3	Other descriptive name	CALCIFEDIOL
D.3.9.4	EV Substance Code	SUB06045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
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

Secondary hyperparathyroidism after renal transplantation

Hiperparatiroidismo secundario después del trasplante renal

E.1.1.1

Medical condition in easily understood language

Secondary hyperparathyroidism after transplantation of the kidney

Hiperparatiroidismo secundario después de trasplante de riñón

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10020708
E.1.2	Term	Hyperparathyroidism secondary
E.1.2	System Organ Class	10014698 - Endocrine disorders

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 demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

Demostrar la superioridad del paricalcitol, en el post-trasplante renal precoz (M6), en el control de iPTH comparado con el uso de suplementos de vitamina D nutricional (calcifediol) en pacientes con trasplante renal.

E.2.2

Secondary objectives of the trial

1.Reduction of aloinmune response of the receptor
2.Effects on the renal function and proteinuria parameters
3.Effects on blood pressure and speed of pulse wave
4.Effects on bone health (mineral density)
5.Frequency of related adverse events in each treatment group.
6.Subclinical rejection (cellular and humoral), chronic damage and presence of calcification on protocol biopsy on each treatment group.
7.Variation on specific markers of bone remodeling and bone mineral metabolism in each treatment group.
8.Presence of anti-HLA antibodies (preformed antibodies, PRA) in each treatment group.
9.Detection of aloreactive T memory cells against donor?s antigens in each treatment group.

1.Reducción de la respuesta aloinmune del receptor.
2.Efectos sobre los parámetros de función renal y proteinuria.
3.Efecto sobre la tensión arterial y la velocidad de la onda de pulso.
4.Efecto sobre la salud ósea (densidad mineral).
5.Frecuencia de eventos adversos relacionados en ambos grupos de tratamiento.
6.Rechazo subclínico (humoral y celular), el daño crónico y la presencia de calcificación en la biopsia de protocolo en ambos grupos de tratamiento.
7.Variación en marcadores específicos de remodelado óseo y metabolismo óseo mineral en ambos grupos de tratamiento.
8.Presencia de anticuerpos anti-HLA (anticuerpos preformados, PRA) en ambos grupos de tratamiento.
9.Detección de células T de memoria aloreactivas contra antígenos del donante en ambos grupos de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.-Patients that have willingly signed and dated the ICD approved by the EC before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
2.-Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
3.-24 hours previous to the transplantation patient must have iPTH levels between 250 and 600 pg/mL as per central laboratory results.
4.-Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
5.-Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
6.-Patients that are to be treated with immunosupresion based on tacrolimus, mofetil micofenolate or micofenolic acid and with steroids and that are not going to be treated with mTOR inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation.
7.-Patients that are able to take oral capsules on the first week post-transplantation.

1.-Sujetos que hayan firmado y fechado, antes de cualquier procedimiento específico del estudio, voluntariamente el formulario de consentimiento informado aprobado por los CEIC, después de que se les haya explicado la naturaleza del estudio, lo hayan leído y hayan tenido la oportunidad de hacer preguntas sobre el mismo.
2.-Pacientes de ambos sexos y mayores de 18 años, candidatos a ser receptores inmediatos de trasplante renal de donante vivo o cadavérico.
3.-En las 24 horas previas al trasplante, el paciente debe tener unos niveles de iPTH situados entre 250 y 600 pg/mL según resultado del laboratorio central.
4.-Pacientes con un panel de anticuerpos preformados (PRA) <20% en las 24 horas previas al trasplante o considerados por el investigador como de bajo riesgo inmunológico (la determinación del porcentaje PRA no se realizará de forma centralizada, sino en el laboratorio de cada centro participante).
5.-Calcio sérico (corregido por la albúmina) < 10 mg/dl, en las 24 horas previas al trasplante según resultado del laboratorio central.
6.-Pacientes que vayan a ser tratados con inmunosupresión basada en tacrolimus, con mofetil micofenolato ó acido micofenólico y con esteroides y que no vayan a ser tratados con inhibidores de la mTOR. No se deberá retirar de forma precoz el tacrolimus ni los esteroides (en los primeros 6 meses postrasplante).
7.-Pacientes que sean capaces de tomar comprimidos por vía oral en la primera semana después del trasplante.

E.4

Principal exclusion criteria

1.-Third or subsequent renal transplantation.
2.-Positive cross-match assay or ABO incompatibility
3.-Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
4.-Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
5.-Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsortion.
6.-Patient with hypo or hyperthyroidism not controlled based on investigators criteria.
7.-Patient with uncontrolled hypertension based on investigators criteria.
8.-Patients that, 48 hours previous to transplantation, have been receiving calcimimetics.
9.-Patients with VIH infection of positive serology for HBV and/or HCV
10.-Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC)
11.-Patients that are participating on other clinical trial with investigational drugs.
12.-Women of childbearing potential (defined as those whose last menstruation was <2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment.
13.-Patient with other diseases or conditions that based on investigators criteria are not suitable for the study.

1.-Tercer o subsecuente trasplante renal.
2.-Prueba cross-match positiva o ABO incompatible.
3.-Paciente que haya sido o vaya a ser receptor de otro trasplante de órgano además del riñón o bien un trasplante renal doble.
4.-Sujetos con antecedentes de reacción alérgica o de sensibilidad manifiesta a paricalcitol, calcifediol o a fármacos similares a los del estudio (relativos a vitamina D).
5.-Sujetos con enfermedad gastrointestinal crónica que, de acuerdo con la opinión del investigador, pueda causar mala absorción gastrointestinal significativa.
6.-Sujetos con hipo o hipertiroidismo no controlado en opinión del investigador.
7.-Sujetos con hipertensión no controlada en la opinión del investigador.
8.-Pacientes que, en las 48 horas previas al trasplante, hayan estado recibiendo calcimimético.
9.-Pacientes con infección por VIH o con serología positiva para VHB y/o VHC.
10.-Pacientes en tratamiento con fármacos contraindicados con paricalcitol o con calcifediol (según las respectivas Fichas Técnicas).
11.-Pacientes que estén participando en otro ensayo clínico con medicamentos en investigación.
12.-Mujeres potencialmente fértiles (que se definen como aquellas que han tenido su última menstruación hace <2 años y no están esterilizadas quirúrgicamente) que no se comprometan a correcta anticoncepción durante el tratamiento del estudio.
13.-Pacientes con otras enfermedades o condiciones que en opinión del investigador no sean aptos para el estudio.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with iPTH serum concentration >110 pg/mL 6 month post-transplantation after starting treatment study o the 7 first days post-transplantation.

Porcentaje de pacientes con concentraciones séricas de iPTH > 110 pg/mL a los 6 meses postrasplante después de comenzar el tratamiento del estudio en los primeros 7 días postrasplante.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 month post-transplantation after starting treatment study o the 7 first days post-transplantation.

6 meses postrasplante después de comenzar el tratamiento del estudio en los primeros 7 días postrasplante.

E.5.2

Secondary end point(s)

1-Changes on iPTH serum concentration 6 month post-transplantation and treatment in each group of treatment.
2-Percentage of patients with at least a reduction of iPTH >=30% from basal level throughout the study.
3-Percentage of patients that reach at least 30% reduction of iPTH at the end of the study.
4-Percentage of patients with iPTH levels between 70-110 pg at the end of the study.
5-Percentage of patients with calcifications o the renal biopsies 6 months after treatment in each study group.
6-Compared and separated incidence of each of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.
7-Presence of aloreactive T memory cells against donor?s antigen at 6 months post-transplantation and treatment in each study group.
8-Change on concentration of bone markers (alkaline phosphatase and osteocalcina) and FGF-23 at 6 months post-transplantation and treatment in each study group.
9-Percentage of patients with acute rejection at 6 months post-transplantation and treatment in each study group.
10-Percentage of patients with delayed graft function rejection at 6 months post-transplantation and treatment in each study group.
11-Percentage of patients with microalbuminuria at 1, 3 and 6 months post-transplantation.
12-Percentage of patients on each stage of renal function at 1,3 and 6 months post-transplantation.
13-Evolution of blood pressure, of the speed of pulse wave, calcium-phosphorus metabolic parameters throughout the study and evolution of bone mineral density at 6 months post-transplantation.
14-Percentage of patients with hypercalcemia (defined as serum calcium levels >10,3 mg/dl) in each study group at month 6 post-transplantation..
15-Evolution of anti-HLA antibodies (PRA) from basal to month 6 post-transplantation.
16-Safety follow up recording any adverse event or serious adverse event that occurs during the study on each treatment group.

1-Cambio en la concentración sérica de iPTH a los 6 meses postrasplante y de tratamiento en cada grupo de estudio.
2-Porcentaje de pacientes que tienen al menos una reducción de iPTH >=30% con respecto al valor basal, a lo largo del estudio.
3-Porcentaje de pacientes que alcanzan al menos un 30% de reducción de iPTH al final del estudio (M6).
4-Porcentaje de pacientes con niveles de iPTH entre 70-110 pg/mL al final del estudio (M6).
5- Porcentaje de pacientes con presencia de calcificaciones en las biopsias renales de protocolo a los seis meses después del tratamiento en cada uno de los grupos de estudio.
6-Incidencia comparada y separada de cada uno de los siguientes eventos: rechazo agudo, rechazo agudo confirmado por biopsia (BPAR) y/o rechazo subclínico (ScR) y/o daño crónico (IFTA).
7-Presencia de células T memoria aloreactivas contra los antígenos del donante a los seis meses postrasplante y tratamiento en cada uno de los grupos de estudio.
8-Cambio en la concentración de marcadores óseos (osteocalcina y fosfatasa alcalina) y de FGF-23 a los 6 meses postrasplante y de tratamiento en cada grupo de estudio.
9-Porcentaje de pacientes con rechazo agudo a los 6 meses postrasplante y después del tratamiento, en cada grupo de estudio.
10-Porcentaje de pacientes con función retardada del injerto (DGF) a los 6 meses postrasplante y después del tratamiento, en cada grupo de estudio.
11-Porcentaje de pacientes con microalbuminuria en los meses 1, 3 y 6 postrasplante.
12-Porcentaje de pacientes en cada uno de los estadíos de función renal en los meses 1, 3 y 6 postrasplante.
13-Evolución de la tensión arterial (MAPA en los centros donde sea viable), de la velocidad de la onda de pulso (en los centros donde sea viable), de los parámetros del metabolismo calcio-fósforo a lo largo del estudio, y evolución de la densidad mineral ósea a los 6 meses postrasplante.
14-Porcentaje de pacientes con hipercalcemia (definido como niveles de calcio séricos >10,3 mg/dl) en cada grupo de tratamiento al mes 6 postrasplante.
15-Evolución de los anticuerpos anti-HLA (PRA) desde el momento basal al mes 6 postrasplante.
16-Seguimiento de seguridad recogiendo cualquier acontecimiento adverso (AA) o acontecimiento adverso grave (AAG) que ocurra durante el estudio en cada grupo de tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 3 and 6 months.

1, 3 y 6 meses.

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

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

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

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:

170

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

180

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

Ninguno

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

2013-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-11

P. End of Trial
P.	End of Trial Status	Completed

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