Clinical Trials Register

Summary
EudraCT Number:	2017-001065-24
Sponsor's Protocol Code Number:	FABOLUSFASTER
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:	2020-11-04
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

2017-001065-24

A.3

Full title of the trial

Facilitation through Aggrastat or cangrelor Bolus and infusion Over prasugreL: a muUlticenter randomized open-label trial in patientS with ST-elevation myocardial inFarction referred for primAry percutaneouS inTERvention.

A.3.1

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

a mUlticenter randomized open-label trial in patients with ST-elevation myocardial inFarction referred for primAry percutaneouS inTERvention.

Studio randomizzato multicentrico in pazienti con infarto miocardico con sopraslivellamento del tratto ST (STEMI) sottoposti ad angioplastica primaria.

A.3.2

Name or abbreviated title of the trial where available

FABOLUS FASTER

A.4.1

Sponsor's protocol code number

FABOLUSFASTER

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02978040

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	INSEL GRUPPE AG, BERN UNIVERSITY HOSPITAL, DEPARTMENT OF CARDIOLOGY
B.1.3.4	Country	Switzerland
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	Medicure Inc.
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Insel Gruppe AG, Bern University Hospital
B.5.2	Functional name of contact point	Cardiologia
B.5.3	Address:
B.5.3.1	Street Address	Freiburgstrasse 4
B.5.3.2	Town/ city	Bern
B.5.3.3	Post code	3010
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41316324714
B.5.5	Fax number	+41316324771
B.5.6	E-mail	marco.valgimigli@insel.ch

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	KENGREXAL - 50 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INIEZIONE/INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 10 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	CHIESI FARMACEUTICI S.P.A.
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	Kengrexal
D.3.2	Product code	[CANGRELOR. Si segnala che il codice ATC di seguit
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cangrelor
D.3.9.1	CAS number	163706-06-7
D.3.9.2	Current sponsor code	N.D.
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	AGGRASTAT - 250 MICROGRAMMI/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 50 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	CORREVIO (UK) LTD
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	Aggrastat
D.3.2	Product code	[Aggrastat]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIROFIBAN CLORIDRATO MONOIDRATO
D.3.9.1	CAS number	144494-65-5
D.3.9.2	Current sponsor code	Tirofiban
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	EFIENT - 5MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
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	Efient
D.3.2	Product code	[Efient]
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	PRASUGREL
D.3.9.1	CAS number	150322-43-3
D.3.9.2	Current sponsor code	N.D.
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.2.1.1.1	Trade name	EFIENT - 5MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
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	Efient
D.3.2	Product code	[Efient]
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	Prasugrel
D.3.9.1	CAS number	150322-43-3
D.3.9.2	Current sponsor code	n.d.
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

myocardial infarction

Infarto miocardico

E.1.1.1

Medical condition in easily understood language

Infarction

Infarto

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	PT
E.1.2	Classification code	10000891
E.1.2	Term	Acute myocardial infarction
E.1.2	System Organ Class	10007541 - Cardiac 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 assess the inhibition of platelet aggegation in the early phase of primary PCI (i.e. 30 minutes after star of treatment as primary study endpoint).

Valutare l’inibizione dell’aggregazione piastrinica in fase precoce dell’angioplastica primaria (l’endpoint primario è a 30 minuti dopo l’inizio del trattamento).

E.2.2

Secondary objectives of the trial

To assess the inhibition of platelet aggegation up to 6 hours after the treatment; pharmacokynetic evaluation (dosage of the active prasugrel metabolite) in patients of the prasugrel group (chewed tablets compared to whole tablets); evaluation of adverse clinical events in all patients and evaluation of alterations (extension of myocardial and microvascular damage) to cardiac magnetic resonance in patients who will provide consent to participate in this sub-study.

Valutare l’inibizione dell’aggregazione piastrinica fino a 6 ore dopo il trattamento; valutazione farmacocinetica (dosaggio del metabolita attivo del prasugrel) nei pazienti del gruppo prasugrel (compresse masticate rispetto a compresse intere); valutazione degli eventi clinici avversi in tutti i pazienti e valutazione delle alterazioni (estensione del danno miocardico e microvascolare) alla risonanza magnetica cardiaca nei pazienti che forniranno il consenso a partecipare a tale sottostudio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients diagnosed with STEMI addressed for primary angioplasty

Pazienti con diagnosi di STEMI indirizzati per angioplastica primaria

E.4

Principal exclusion criteria

- Unconsciousness and other conditions that make the patient incapable of receiving integer oral loading dose of prasugrel;
- bleeding diathesis;
- recent administration of fibrinolytic or glycoprotein IIb / IIIa or P2Y12 inhibitors or cangrelor receptor;
- chronic dialysis;
- previous intracranial hemorrhage;
- previous cerebral stroke or recent transient ischemic attack;
- known hypersensitivity to study drugs;
- need for oral anticoagulant therapy;
- pregnancy or breastfeeding;
- limited life expectancy.

- Incoscienza e altre condizioni che rendono il paziente incapace di assumere la dose di carico orale di prasugrel;
- diatesi emorragica;
- recente somministrazione di fibrinolitici o inibitori della glicoproteina IIb/IIIa o del recettore P2Y12 o cangrelor;
- dialisi;
- pregressa emorragia intracranica;
- pregresso ictus cerebrale o recente attacco ischemico transitorio;
- nota ipersensibilità ai farmaci in studio;
- necessità di terapia anticoagulante orale;
- gravidanza o allattamento;
- limitata aspettativa di vita.

E.5 End points

E.5.1

Primary end point(s)

The primary end-point of the study is the percentage of inhibition of platelet activity (IPA) at light transmission aggregometry (LTA) in a platelet-rich plasma stimulated with ADP 20 µmol/l after 30 minutes from the administration of the randomised drug.

Valutare l'inibizione piastrinica definita mediante aggregometria (light transmission aggregometry; LTA) in plasma rico di piastrine dopo aggiunta di ADP 20 micromol/l dopo 30 minuti dalla somministrazione del farmaco randomizzato.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 minutes

30 minuti

E.5.2

Secondary end point(s)

- LTA with TRAP at a concentration of 5 and 15 µmol / l, and ADP at a concentration of 5 µmol / l at all different times (before the procedure, at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4- 6 hours)) and ADP at 20 µmol / l before the procedure, 15 minutes, 1h, 2h, 3h, 4-6h).
- Multiplate analysis using ADP and TRAP as agonists at all times previously specified;
- Pharmacokinetic analysis of the active metabolite of prasugrel in patients of the prasugrel group (chewed tablets compared to whole tablets) at different study times;
- Electrocardiographic analysis with evaluation of the resolution of the ST segment elevation and of the residual ST grade elevation immediately after angioplasty and 90 minutes after the procedure;
- Angiographic analysis of reperfusion parameters (final TIMI flow, corrected TIMI frame count and myocardial blush);
- Adverse clinical events at 48 hours and 30 days;
- In patients who will participate in the imaging substudy, the cardiac morpho-functional alterations found on cardiac MRI will be evaluated;
- Cost-effectiveness analysis with evaluation of direct and indirect costs in relation to clinical events;

- LTA con TRAP a concentrazione di 5 and 15 µmol/l, e ADP a concentrazione di 5 µmol/l a tutti i diversi tempi (prima della procedura, a 15 minuti, 30 minuti, 1 ora, 2 ore, 3 ore, 4-6 ore)) e ADP a 20 µmol/l prima della procedura, 15 minutes, 1h, 2h, 3h, 4-6h).
- Analisi Multiplate usando ADP e TRAP come agonisti a tutti i tempi precedentemente specificati;
- Analisi farmacocinetica con dosaggio del metabolita attivo del prasugrel nei pazienti del gruppo prasugrel (compresse masticate rispetto a compresse intere) ai diversi tempi di studio;
- Analisi elettrocardiografica con valutazione della risoluzione del sopraslivellamento del tratto ST e del grado di sopraslivellamento ST residuo immediatamente dopo l’angioplastica e 90 minuti dopo la procedura;
- Analisi angiografica dei parametri di riperfusione (flusso TIMI finale, corrected TIMI frame count e blush miocardico);
- Eventi clinici avversi a 48 ore e a 30 giorni;
- Nei pazienti che parteciperanno al sottostudio di imaging, saranno valutate le alterazioni morfo-funzionali cardiache riscontrate alla risonanza magnetica cardiaca;
- Analisi costo-efficacia con valutazione dei costi diretti e indiretti in relazione agli eventi clinici;

E.5.2.1

Timepoint(s) of evaluation of this end point

15 min, 1 hour, 2 hours, 3 hours, 4-6 hours, 1.5 hours after the procedure, 48 hours, 30 days

15 min, 1 ora, 2 ore, 3 ore, 4-6 ore, 1,5 ore dopo la procedura, 48 ore, 30 giorni

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

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

Yes

E.6.13.1

Other scope of the trial description

Aggrastat or Cangrelor bolus and infusion compared with Prasugrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary angioplasty.

Aggrastat o Cangrelor in bolo e infusione rispetto a Prasugrel in pazienti con infarto miocardico con sopraslivellamento del tratto ST (STEMI) sottoposti ad angioplastica primaria.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

IMP2, IMP3

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

Information not present in EudraCT

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

Switzerland

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

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

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:

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

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

120

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)

Follow-up according to clinical practice

Follow-up in accordo alle normali pratiche cliniche

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

2018-06-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-27

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

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Clinical trials