Clinical Trials Register

Summary
EudraCT Number:	2014-002606-20
Sponsor's Protocol Code Number:	CV185-325/B0661037
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Not Authorised
Date on which this record was first entered in the EudraCT database:	2017-09-11
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

2014-002606-20

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

STUDIO RANDOMIZZATO, IN APERTO, CONTROLLATO CON CONTROLLO ATTIVO SULLA SICUREZZA E SULL’EFFICACIA ESTRAPOLATA IN SOGGETTI PEDIATRICI CHE RICHIEDONO UNA TERAPIA ANTICOAGULANTE PER IL TRATTAMENTO DI UN EVENTO TROMBOEMBOLICO VENOSO

A.3.1

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

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

A.4.1

Sponsor's protocol code number

CV185-325/B0661037

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1160-6336

A.5.4

Other Identifiers

Name:

USA IND Number

Number:

66,106

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/235/2013

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU Representative
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.5	Fax number	+3223517164
B.5.6	E-mail	gct-su@bms.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	No
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	apixaban
D.3.2	Product code	BMS-562247-01
D.3.4	Pharmaceutical form	Oral solution
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	APIXABAN
D.3.9.2	Current sponsor code	PF-0465257/BMS-562247-01
D.3.9.4	EV Substance Code	SUB25425
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	0.4
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	No
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	apixaban
D.3.2	Product code	PF-04652577/BMS-562247-01
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	APIXABAN
D.3.9.2	Current sponsor code	PF-04652577/BMS-562247-01
D.3.9.4	EV Substance Code	SUB25425
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	5
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	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.2.1.2	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
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	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.2.1.2	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
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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

Venous Thromboembolism

Evento Tromboembolico Venoso

E.1.1.1

Medical condition in easily understood language

Blood Clot

Coagulo di sangue

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10043565
E.1.2	Term	Thromboembolic event
E.1.2	System Organ Class	100000023033

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Valutare la sicurezza e l’efficacia estrapolata di apixaban in soggetti pediatrici che richiedono una terapia anticoagulante per il trattamento di un episodio di TEV

E.2.2

Secondary objectives of the trial

To evaluate apixaban pharmacokinetic (PK) and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Valutare la farmacocinetica (PK) e l’attività anti-FXa di apixaban in soggetti pediatrici che richiedono una terapia anticoagulante per il trattamento di un episodio di TEV.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Children 2 to <18 years of age at the time of consent (Age Groups 1 and 2). An approved protocol will be implemented prior to enrolment of each subsequent age group.

2.Presence of an index VTE which is confirmed by imaging. Index VTE include, but are not limited to, deep vein thrombosis, pulmonary embolus, cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, and splanchnic thrombosis.

3.Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks or intention to manage the index VTE with anticoagulation treatment in neonates for at least 6 weeks.

4.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Depending on local regulations, whenever the minor is able to give assent, the minor’s assent must also be obtained.

5.Subjects/legally acceptable representatives who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

6.Female subjects who, in the opinion of the investigator, are biologically capable of having children and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 33 days (5 half-lives plus 30 days) after the last dose of assigned treatment.

1. Bambini di età da 2 a <18 anni al momento del consenso (Gruppi di età 1 e 2).
• Prima dell’arruolamento di ogni gruppo di età successivo sarà implementato un protocollo emendato approvato.
2. Presenza di un evento indice di TEV confermato dagli esami di imaging. Gli eventi indice di TEV includono, in modo non limitativo, trombosi venosa profonda, embolia polmonare, trombosi dei seni venosi cerebrali, trombosi della vena renale, trombosi della vena porta e trombosi splancnica.
3. Intenzione di gestire l’evento indice di TEV con un trattamento anticoagulante per almeno 12 settimane o, nei neonati, intenzione di gestire l’evento indice di TEV con un trattamento anticoagulante per almeno 6 settimane.
4. Dimostrazione di un documento di consenso informato personalmente firmato e datato, indicante che il soggetto (o un rappresentante legalmente accettabile) è stato informato su tutti gli aspetti pertinenti allo studio. A seconda delle disposizioni locali, qualora il minore sia in grado di fornire il proprio assenso, deve essere acquisito anche l’assenso del minore.
5. Soggetti/rappresentanti legalmente accettabili che intendono e sono in grado di attenersi alle visite in programma, al piano di trattamento, agli esami di laboratorio e alle altre procedure previste dallo studio.
6. I soggetti di sesso femminile che, a giudizio dello sperimentatore, sono biologicamente in grado di avere figli e sono sessualmente attivi e a rischio di gravidanza devono acconsentire a utilizzare un metodo contraccettivo altamente efficace per tutta la durata dello studio e per almeno 33 giorni (5 emivite più 30 giorni) dopo l’ultima dose del trattamento assegnato

E.4

Principal exclusion criteria

1. Anticoagulant treatment for the index VTE for greater than 7 days prior to randomization.

2. Cerebral sinovenous thrombosis (in Germany only).

3. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE

4. A mechanical heart valve

5.Active bleeding or high risk of bleeding (e.g. central nervous system (CNS) tumors) at the time of randomization.

6.Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.

7.Abnormal baseline liver function (ALT > 3 x upper limit of normal (ULN) or conjugated bilirubin > 2x ULN) at randomization.

8.At the time of randomization, inadequate renal function as defined in Section 7.2.2 Estimated Glomerular Filtration Rate Assessment of the protocol.

9.Platelet count < 50×109 per L at randomization.

10.At the time of randomization, uncontrolled severe hypertension as defined in Section 7.1 Physical Examination of the protocol.

11.At the time of randomization, use of prohibited concomitant medication as listed for apixaban in Section 5.5 Concomitant Medication of the protocol.

12.Known allergy to apixaban.

13.Female subjects who are either pregnant or breastfeeding a child.

14.Geographically unavailable for follow-up.

15.Family members who are either investigational site staff members directly involved in the conduct of this trial or site staff members otherwise supervised by the Investigator. Family members who are Pfizer or Bristol Myers Squibb (BMS) employees directly involved in the conduct of this trial.

16.Taking an investigational drug in other studies within 30 days before the first dose of apixaban and/or during study participation. N.B. using marketed medications commonly used in usual and customary practice, though not labeled for use in children, is acceptable.

17.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

1. Trattamento anticoagulante per l’evento indice di TEV per più di 7 giorni prima della randomizzazione.
2. Trombosi dei seni venosi cerebrali (solo in Germania).
3. Trombectomia, terapia trombolitica o inserimento di un filtro cavale per il trattamento dell’evento indice di TEV.
4. Valvola cardiaca meccanica.
5. Emorragia attiva o alto rischio di emorragia (ad es., tumori del sistema nervoso centrale [SNC]) al momento della randomizzazione.
6. Emorragia intracerebrale, inclusa l’emorragia intraventricolare, nei 3 mesi precedenti la randomizzazione.
7. Funzionalità epatica basale anormale (ALT >3x il limite superiore della normalità [ULN] o bilirubina coniugata >2x l’ULN) alla randomizzazione.
8. Al momento della randomizzazione, funzionalità renale inadeguata secondo la definizione fornita nella Sezione 7.2.2 del protocollo “Valutazione della velocità di filtrazione glomerulare stimata”.
9. Conta piastrinica <50×109 per L alla randomizzazione.
10. Al momento della randomizzazione, ipertensione grave non controllata secondo la definizione fornita dal protocollo nella Sezione 7.1 Esame obiettivo.
11. Al momento della randomizzazione, utilizzo di un farmaco concomitante non consentito, come elencato per apixaban nella Sezione 5.5 del protocollo “Farmaci concomitanti”.
12. Allergia nota ad apixaban.
13. Soggetti di sesso femminile in gravidanza o allattamento.
14. Mancata disponibilità geografica per il follow-up.
15. Famigliari che appartengono al personale del centro sperimentale direttamente coinvolto nella conduzione di questa sperimentazione, o sono membri del personale del centro altrimenti supervisionati dallo sperimentatore. Famigliari che sono dipendenti di Pfizer o di Bristol Myers Squibb (BMS) direttamente coinvolti nella conduzione di questa sperimentazione.
16. Assunzione di un farmaco sperimentale nell’ambito di altri studi entro 30 giorni prima della prima dose di apixaban e/o durante la partecipazione allo studio. N.B. L’uso di farmaci disponibili in commercio comunemente impiegati nella pratica normale e consueta, sebbene non approvati per l’uso nei bambini, è considerato accettabile.
17. Altra condizione medica o psichiatrica grave, acuta o cronica, oppure valori di laboratorio non normali che possano aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale, o che possano interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renderebbero il soggetto non idoneo ad accedere allo studio.

E.5 End points

E.5.1

Primary end point(s)

Primary Safety: The composite of major and clinically relevant non-major bleeding.

Primary Efficacy: A composite of: (i) all image-confirmed and adjudicated symptomatic and asymptomatic recurrent VTE defined as either contiguous progression or non-contiguous new thrombus and including DVT, PE and paradoxical embolism and (ii) VTE-related mortality.

• Sicurezza primaria: il composito di sanguinamento maggiore e sanguinamento non maggiore clinicamente rilevante.
• Efficacia primaria: un composito di: (i) tutti gli eventi confermati dagli esami di imaging e aggiudicati di TEV ricorrente, sintomatica e non, definita come progressione contigua o nuovo trombo non contiguo e comprendente TVP, EP ed embolia paradossa, e (ii) mortalità correlata alla TEV.

E.5.1.1

Timepoint(s) of evaluation of this end point

Listed with Endpoints

Elencati negli Endpoints

E.5.2

Secondary end point(s)

• All cause death
• Index VTE status (e.g. unchanged, regression, or resolution)
• Stroke
• New symptomatic or asymptomatic DVT
• New symptomatic PE
• Apixaban concentrations
• Anti-FXa activity

• Tutte le cause di decesso
• Status Index TEV (e.g. progressione, regressione, o risoluzione)
• Ictus
• Nuova DVT sintomatica o asintomatica
• nuova PE sintomatica
• concentrazioni di Apixaban
• Attività Anti-FXa

E.5.2.1

Timepoint(s) of evaluation of this end point

Listed with endpoints

Elencati negli Endpoints

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

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

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

Austria

Canada

Germany

Italy

Russian Federation

Ukraine

United States

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

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

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

Yes

F.1.1

Number of subjects for this age range:

150

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Pediatric population

popolazione pediatrica

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

150

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

nessuno

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

2018-01-17

Ethics Committee Opinion of the trial application

Not-Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-17

P. End of Trial
P.	End of Trial Status	Not Authorised

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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