Clinical Trials Register

Summary
EudraCT Number:	2021-000730-34
Sponsor's Protocol Code Number:	ARMYDA-AMULET
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:	2021-06-08
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

2021-000730-34

A.3

Full title of the trial

HeAd-to-head compaRison of single versus dual antiplatelet treatMent strategY after percutaneous left atrial appenDAge closure: A MULticenter, randomizEd sTudy
the ARMYDA-AMULET study

Confronto tra singola e doppia terapia antipiastrinica in pazienti sottoposti a chiusura percutanea di auricola sinistra (studio randomizzato multicentrico ARMYDA-AMULET)

A.3.1

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

Comparison between single and dual therapy with drugs that inhibits platelet aggregation in patient undergoing the percutaneous left atrial appenDAge closure (ARMYDA-AMULET in which people will be allocated by chance to receive two different options of treatment and which will involves different clinical sites).

Confronto tra singola e doppia terapia con farmaci in grado di ostacolare l'aggregazione piastrinica in pazienti sottoposti a chiusura percutanea di auricola sinistra (studio ARMYDA-AMULET in cui le due differenti opzioni di trattamento verranno assegnate in modo casuale e che si svolgerà in più centri clinici).

A.3.2

Name or abbreviated title of the trial where available

A MULticenter, randomizEd sTudy the ARMYDA-AMULET study

Studio randomizzato multicentrico ARMYDA-AMULET

A.4.1

Sponsor's protocol code number

ARMYDA-AMULET

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 TOSCANA GABRIELE MONASTERIO
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	Abbott Medical Italia Spa
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	Consorzio per Valutazioni Biologiche e Farmacologiche
B.5.2	Functional name of contact point	Servizio Regolatorio
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Porta, 14
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	038225075
B.5.5	Fax number	0382536544
B.5.6	E-mail	ricercaclinica@cvbf.net

D. IMP Identification
D.IMP: 1
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.2.5	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	clopidogrel 75
D.3.2	Product code	[NA]
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	CLOPIDOGREL
D.3.9.1	CAS number	113665-84-2
D.3.9.2	Current sponsor code	NA
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	75
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	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.2.5	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	Aspirina 325
D.3.2	Product code	[NA]
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	ACIDO ACETILSALICILICO
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Acetylsalicylic acid
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	325
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	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.2.5	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	clopidogrel 300
D.3.2	Product code	[NA]
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	CLOPIDOGREL
D.3.9.1	CAS number	113665-84-2
D.3.9.2	Current sponsor code	NA
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	300
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	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.2.5	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	Aspirina 100
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Gastro-resistant 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	ACIDO ACETILSALICILICO
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	acetylsalicylic acid
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	100
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

Patients with atrial fibrillation undergoing percutaneous left atrial appendage closure with the Amulet device

Pazienti con fibrillazione atriale sottoposti a chiusura percutanea dell'auricola sinistra con il dispositivo Amulet

E.1.1.1

Medical condition in easily understood language

Patient with irregular heartbeat undergoing percutaneous left atrial appendage closure

Pazienti con alterazione del ritmo del cuore sottoposti a chiusura percutanea dell'auricola sinistra

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	10016566
E.1.2	Term	Fibrillation atrial
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate that the strategy with single antiplatelet therapy (SAPT) is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.

Dimostrare che la strategia con singola terapia antipiastrinica (SAPT) non è inferiore all'attuale terapia antipiastrinica standard (DAPT) dopo la chiusura della LAA per quanto riguarda l'incidenza cumulativa dell'endpoint composito netto, inclusi morte, complicanze trombotiche ed eventi di sanguinamento, a 6 mesi.

E.2.2

Secondary objectives of the trial

Compared to DAPT, SAPT use is associated with a similar incidence of ischemic events and a significantly lower incidence of bleeding complications at 6 months.

Rispetto al DAPT, l'uso di SAPT è associato a un'incidenza simile di eventi ischemici e un'incidenza significativamente inferiore di complicanze emorragiche a 6 mesi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Men or women aged =18 years signing a specific informed consent
-Patients with a planned percutaneous LAA closure;
-Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2
-Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities,
history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy.
-Patient’s availability to undergo the follow-up visits scheduled for the study
-Negative pregnancy testing (if applicable), performed at the time of enrollment.

- Uomini o donne di età =18 anni che hanno firmato un consenso informato specifico
- Pazienti per cui è già stata programmata procedura di chiusura dell’Auricola sinistra
- Pazienti con fibrillazione atriale (FA) non valvolare documentata, indipendentemente dal tipo (parossistico, permanente, persistente) e punteggio CHA2DS2-VASc =2
- Pazienti considerati non idonei alla terapia anticoagulante orale a lungo termine a causa di un alto rischio di sanguinamento. I pazienti saranno giudicati inadatti alla terapia anticoagulante a causa di
comorbidità soggette a sanguinamento, storia di sanguinamento precedente (con o senza trattamento anticoagulante) o un'attesa scarsa aderenza alla terapia.
- Disponibilità del paziente a sottoporsi alle visite di follow-up previste per lo studio
- Test di gravidanza negativo (se applicabile), eseguito al momento dell'iscrizione.

E.4

Principal exclusion criteria

-CHADS-VAsc score 0-1
-Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
-Known hypersensitivity to the study drugs (aspirin or clopidogrel)
-Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
-Planned oral anticoagulant therapy after the procedure
-Moderate to severe mitral stenosis
-Mechanical heart prosthetic valve
-Active endocarditis
-Active bleeding
-Myocardial infarction or percutaneous coronary intervention <6 months
-Major surgery within one month
-Intracranial neoplasm, aneurysm or arterio-venous malformation
-Platelet count <50,000/µL
-Recent stroke (<1 month)
-Fibrinolytic therapy within 10 days
-Baseline hemoglobin <9 g/dL
-Pregnant woman
-Breast-feeding
-Women unavailable to use contraception during the study period

- CHADS-VAsc score 0-1
- Pazienti in terapia con clopidogrel al momento dello screening (es. la terapia in corso con clopidogrel al momento dello screening costituirà un criterio di esclusione)
- Nota ipersensibilità ai farmaci usati nello studio (aspirina o clopidrogel)
- Pazienti impossibilitati alla terapia antipiastrinica (SAPT o DAPT) per 6 mesi a causa di un elevato rischio di sanguinamento recente (<1 mese)
- Pazienti che riceveranno una terapia anticoagulante dopo la procedura
- Stenosi mitralica da moderata a severa
- Impianto di valvola cardiaca meccanica
- Endocardite in corso
- Sanguinamenti in corso
- Infarto Miocardico (MI) o intervento coronarico percutaneo (PCI) nei 6 mesi precedenti
- Interventi chirurgici maggiori entro un mese
- Neoplasia, aneurisma o malformazione arterio-venosa intracranica
- Conta piastrinica <50,000/µL
- Recente ictus (<1 mese)
-Terapia fibrinolitica entro 10 giorni
- Emoglobina basale <9 g/dL
- Donne incinte
- Donne in allattamento
- Donne fertili impossibilitate ad utilizzare contraccettivi durante lo studio

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, device-related thrombosis (DRT) (at 3- or 6-month transesophageal echocardiography (TEE)), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding =3 (7). An independent board for clinical event adjudication and data safety monitoring will be created.

L'endpoint primario sarà l'incidenza a 6 mesi nei due bracci di trattamento (SAPT versus DAPT) dell'endpoint composito netto comprendente morte per tutte le cause, trombosi correlate al dispositivo (DRT) (all'ecocardiografia transesofagea (TEE) eseguita a 3 o 6 mesi), ictus ischemico, eventi embolici sistemici (SEE) o sanguinamento secondo la classificazione BARC =3 (7). Verrà istituito un comitato indipendente per la valutazione degli eventi clinici e il monitoraggio della sicurezza dei dati.

E.5.1.1

Timepoint(s) of evaluation of this end point

6-month

A sei mesi

E.5.2

Secondary end point(s)

The following secondary endpoints will be separately considered and compared in the two arms:
-DRT at 3 and 6 months by TEE
-Any-cause death
-Incidence of ischemic stroke or SEE at 3 and 6 months
-Incidence of any bleeding at 3 and 6 months
-Incidence of BARC classification bleeding =3 at 3 and 6 months

I seguenti endpoint secondari verranno considerati e confrontati separatamente nei due bracci:
- DRT a 3 e 6 mesi secondo la valutazione all’esame TEE
- Morte per qualsiasi causa
- Incidenza di ictus ischemico o SEE a 3 e 6 mesi
- Incidenza di qualsiasi sanguinamento a 3 e 6 mesi
- Incidenza di sanguinamenti secondo la classificazione BARC =3, valutata a 3 e 6 mesi

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoint(s) of evaluation varies depending on the end point. Please refers to section E.5.2.EN for more details.

Il tempo di rilevazione dipende dal tipo di endpoint. Si prega di fare riferimento alla sezione E.5.2.IT per maggiori dettagli.

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

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

Diversa associazione IMP

Different IMP combination

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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:

115

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

459

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

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

574

F.4.2

For a multinational trial

F.4.2.1

In the EEA

574

F.4.2.2

In the whole clinical trial

574

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 clinical practice

Secondo pratica clinica

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

2021-06-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-24

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

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Clinical trials