Clinical Trials Register

Summary
EudraCT Number:	2013-000309-21
Sponsor's Protocol Code Number:	PREDICT_Trial_Amd_04
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
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_Amd_04

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	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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	Italian Ministery of Health
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	Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
B.5.2	Functional name of contact point	UOC Nefrologia, Dialisi e Trapianto
B.5.3	Address:
B.5.3.1	Street Address	Via Commenda, 9
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390255032883
B.5.5	Fax number	+390255032451
B.5.6	E-mail	giovanni.montini@policlinico.mi.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.3.1	Product name	Amoxicilline + clavulanic acid
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotics
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.3.1	Product name	Nitrofurantoina
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotics
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.3.1	Product name	Cefixima
D.3.2	Product code	J01DD
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotics
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.3.1	Product name	Trimetoprim/sulfamethoxazole
D.3.2	Product code	J01EE
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotics

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

Infants with vesicoureteral reflux grade III-V, started before the first symptomatic infection.

Bambini con reflusso vescico-ureterale di alto grado (3°-4°-5°) eventualmente associato a ipodisplasia renale.

E.1.1.1

Medical condition in easily understood language

Infants with abnormalities of the urinary tract (high grade vesicoureteral reflux)

Bambini con anomalie delle vie urinarie (reflusso vescico-ureterale di alto grado)

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	21.1
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 the reduction of symptomatic UTIs in infants with vesicoureteral reflux grade III-V, started before the first symptomatic infection.

L'obiettivo primario è la valutazione dell’efficacia della profilassi antibiotica iniziata in lattanti con diagnosi pre o post natale di anomalie ecografiche dei reni e/o delle vie urinarie associate a reflusso vescico-ureterale di III-V grado, 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 number of new renal scars at the 2 and 5-year follow-up DMSA scan;
4. 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;
5. the hypothetical role of prophylactic antibiotic therapy during the first months of life on BMI at 2 and 5 years of age
6. the modification in gut microbiota induced by continuous antibiotic exposure during the first months of life.

Gli obiettivi secondari sono relativi alla valutazione di:
1. ruolo delle infezioni sintomatiche e febbrili delle vie urinarie nell’insorgenza e nella progressione del danno renale e nell’evoluzione della funzione renale;
2. storia naturale della funzione renale in pazienti pediatrici con anomalie congenite del rene o delle vie urinarie nei primi 5 anni di vita;
3. numero di nuove cicatrici renali (scars) alla scintigrafia con DMSA eseguita a 2 e 5 anni;
4. 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;
5. 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;
6. modifiche del microbiota intestinale indotte da una esposizione prolungata ad antibiotici durante i primi mesi 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
g. No urethal valves

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.
g. Assenza di valvole dell'uretra

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.
j. Presence of urethral valves

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.
j. Presenza di valvole dell'uretra

E.5 End points

E.5.1

Primary end point(s)

The primary end point is the rate of first symptomatic urinary tract infections during the 24-month observation period.

L'end point primario è l’insorgenza di un’infezione urinaria sintomatica durante il periodo di osservazione di 24 mesi.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

Secondary end point(s)

The secondary end points are:
1. febrile UTIs;
2. number of new renal scars at the 2 and 5-year follow-up DMSA scan;
3. development of renal function, hypertension and/or proteinuria, anatomical growth of the kidneys at 2 and 5.year follow-up;
4. evaluation of the natural course of renal function for hypo-dysplastic kidneys during the first 5 years of life; 5. evaluation of BMI at 2 and 5 years of age;
6. modification in gut microbiota induced by continuous antibiotic exposure during the first months of life.

Gli end points secondari sono:
1. le infezioni urinarie febbrili;
2. il numero di cicatrici renali alla scintigrafia con DMSA di controllo dopo 2 e 5 anni;
3. l’evoluzione della funzionalità renale, lo sviluppo di’ipertensione arteriosa e/o proteinuria, la crescita anatomica del rene a 2 e 5 anni;
4. la valutazione della storia naturale della funzione renale per i reni ipo-displasici durante i primi 5 anni di vita;
5. la valutazione del Body Mass Index (BMI) a 2 e a 5 anni di età;
6. la valutazione delle modifiche del microbiota intestinale indotte da una esposizione prolungata ad antibiotici durante i primi mesi di vita.

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

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)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Nessun farmaco somministrato, solo sorveglianza clinica

No drug, only 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

Australia

Turkey

Belgium

Germany

Italy

Lithuania

Poland

Portugal

Spain

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:

290

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:

290

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, Informed Consent must be obtained by parents/tutor

Pazienti minorenni, per cui sarà necessario il Consenso informato dei genitori/tutor

F.4 Planned number of subjects to be included

F.4.1

In the member state

140

F.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

290

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 the most appropriate clinical care, and eventualy therapeutic care

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	Completed

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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