Clinical Trials Register

Summary
EudraCT Number:	2013-000309-21
Sponsor's Protocol Code Number:	PREDICT_Trial
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-06-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-000309-21

A.3

Full title of the trial

Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract

Profilassi antibiotica e danno renale nelle anomalie congenite del rene e delle vie urinarie

A.3.1

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

Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of the kidney and urinary Tract

Profilassi antibiotica e danno renale nelle anomalie congenite del rene e delle vie urinarie

A.3.2

Name or abbreviated title of the trial where available

PREDICT_Trial

A.4.1

Sponsor's protocol code number

PREDICT_Trial

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	AOU di Bologna, Policlinico S.Orsola-Malpighi
B.1.3.4	Country	Italy
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	Ministero della Salute, Project Code:RF-2010-2308451
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AOU di Bologna, Policlinico S.Orsola-Malpighi
B.5.2	Functional name of contact point	G.Montini,S.S.Neforologia Pediatric
B.5.3	Address:
B.5.3.1	Street Address	Via Albertoni 15
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390516364617
B.5.5	Fax number	0039051636617
B.5.6	E-mail	giovanni.montini@aosp.bo.it

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.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	AMOXICILLIN
D.3.9.1	CAS number	26787-78-0
D.3.9.4	EV Substance Code	SUB05481MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLAVULANIC ACID
D.3.9.1	CAS number	58001-44-8
D.3.9.4	EV Substance Code	SUB06642MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	11
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.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NITROFURANTOIN
D.3.9.1	CAS number	67-20-9
D.3.9.3	Other descriptive name	NITROFURANTOIN
D.3.9.4	EV Substance Code	SUB09326MIG
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.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.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Granules for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	CEFIXIME
D.3.9.1	CAS number	79350-37-1
D.3.9.3	Other descriptive name	CEFIXIME
D.3.9.4	EV Substance Code	SUB07395MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	SULFAMETHOXAZOLE
D.3.9.1	CAS number	723-46-6
D.3.9.4	EV Substance Code	SUB10711MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIMETHOPRIM
D.3.9.3	Other descriptive name	TRIMETHOPRIM
D.3.9.4	EV Substance Code	SUB11310MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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

evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection

Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica

E.1.1.1

Medical condition in easily understood language

evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection

Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10047371
E.1.2	Term	Vesicoureteral reflux
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is the evaluation of the effectiveness of antimicrobial prophylaxis in infants with vesico-ureteral reflux grade III-V, started before the first symptomatic infection.

Valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con reflusso vescico-ureterale di III-V, iniziata prima dell’insorgenza della prima infezione urinaria sintomatica.

E.2.2

Secondary objectives of the trial

The secondary objectives are the evaluation of
1. the role of symptomatic and febrile UTIs on the appearance and progression of kidney damage and development of renal function;
2. the natural history of renal function of paediatric patients with congenital kidney or urinary tract anomalies during the first 5 years of life;
3. the natural evolution of vesico-ureteral reflux during the first 5 years of life and its correlation with UTIs, renal scars and impairment of renal function;
4. the hypothetic role of prophylactic antibiotic therapy during the first months of life on BMI at 2 and 5 years of age.

1. Valutazione del ruolo delle infezioni sintomatiche e febbrili delle vie urinarie nell’insorgenza e nella progressione del danno renale e nell’evoluzione della funzione renale.

2. Valutazione della storia naturale della funzione renale in pazienti pediatrici con anomalie congenite del rene o delle vie urinarie nei primi 5 anni di vita.

3. Valutazione dell’evoluzione naturale del reflusso vescico-ureterale durante i primi 5 anni di vita e della sua correlazione con l’insorgenza di Infezioni delle vie Urinarie, cicatrici renali o peggioramento della funzione renale.

4. Valutazione dell’ipotetica influenza di una terapia antibiotica somministrata nei primi mesi di vita sul Body Mass Index (BMI) valutato al 2° e al 5° anno di vita

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a. Age between 1 and 4 months
b. Gestational age > 35 weeks
c. Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2 at three months of age
d. No previous symptomatic UTI
e. Imaging Diagnostic work-up completed and presence of grade III to V vesico-ureteral reflux
f. Informed consent of parents

a. Età compresa tra 1 e 4 mesi all’arruolamento.
b. Eta gestazionale > 35 settimane.
c. Filtrato glomerulare (GFR) calcolato secondo la formula di Schwartz > 15 ml/min/1.73 m2 a 3 mesi di età.
d. Non precedenti Infezioni delle vie Urinarie Sintomatiche.
e. Completamento del work-up radiologico di screening e presenza di reflusso vescico-ureterale di 3°-5° grado.
f. Consenso informato firmato dai genitori.

E.4

Principal exclusion criteria

a. Age <1 and >4 months
b. Gestational age < 35 weeks
c. Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
d. Patients with neurogenic bladder, myelomeningocele, uretero-pelvic junction and/or uretero-vescico junction obstruction, or other malformations leading to potential voiding disturbances, apart from urethral valves
e. Patients with no or low grade reflux (grade I and II).
f. Hypersensitivity to the all the utilized antimicrobial agent
g. Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
h. Use of experimental drugs in the month previous to the beginning of the study
i. Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.

a. Età <1 o >4 mesi.
b. Età gestazionale < 35 weeks.
c. Filtrato glomerulare (GFR) calcolato secondo la formula di Schwartz < 15 ml/min/1.73 m2 a 3 mesi di età.
d. Pazienti con vescica neurologica, mielomeningocele, stenosi del giunto pielo-ureterale, ostruzione della giunzione uretero-vescicale, o altre malformazioni potenzialmente correlate all’insorgenza di disturbi minzionali, eccetto le valvole dell’uretra.
e. Pazienti senza reflusso vescico-ureterale o con reflusso vescico-ureterale di 1°-2° grado.
f. Ipersensibilità a tutti i principi attivi previsti dal protocollo
g. Bambini in condizioni cliniche severe che, a parere dello sperimentatore, non permettano l’arruolamento nella coorte dello studio.
h. L’uso di farmaci nel mese precedente l’arruolamento nello studio.
i. Bambini non in grado di seguire le procedure stabilite dal protocollo o bambini con genitori incapaci di firmare il consenso informato.

E.5 End points

E.5.1

Primary end point(s)

symptomatic urinary tract infection rate during the 24-month observation period.

tasso di infezioni sintomatiche delle vie urinarie durante i 24 mesi di trattamento/osservazione.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

Secondary end point(s)

number of febrile UTIs and of new renal scars (DMSA scan) at the 2 and 5 years follow-up in relation to the development of renal function (creatinine and Cystatin C plasma values, eGFR), hypertension (blood pressure >95th%ile per age, sex and height) and/or proteinuria (protein/creatinine), anatomical growth (renal length) of the kidneys at 2 and 5 years follow-up, evaluation of the natural course of renal function for hypo-dysplastic kidneys during the first 5 years of life

Gli END POINT SECONDARI sono le infezioni urinarie febbrili, il numero di cicatrici renali alla scintigrafia con DMSA di controllo dopo 2 anni; l’evoluzione della funzionalità renale, l’ipertensione arteriosa e/o la proteinuria, la valutazione della storia naturale della funzione renale per i reni ipo-displasici durante i primi 5 anni di vita e la valutazione del Body Mass Index (BMI) a 2 e a 5 anni di età

E.5.2.1

Timepoint(s) of evaluation of this end point

60 months

60 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessun farmaco, solo sorveglianza clinica

NO drug, normal clinical surveillance

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

Belgium

Czech Republic

France

Germany

Hungary

Italy

Lithuania

Poland

Portugal

Serbia

Switzerland

Turkey

United Kingdom

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

436

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

436

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

infants, Consent should be obtained by parents/tutor

minorenni, Consenso informato dovrà essere ottenuto dai genitori /tutor

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

436

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)

according to the clinical conditions will be guaranteed clinical care, and eventualy therapeutic, more appropriate

in base alle condizioni cliniche verrà garantita l'assistenza clinica, ed eventualmente terapeutica, più appropriata

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	ESCAPE group
G.4.3.4	Network Country	Germany

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-16

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

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Clinical trials