Clinical Trials Register

Summary
EudraCT Number:	2022-003912-99
Sponsor's Protocol Code Number:	CMP-MYTHiC
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:	2023-02-20
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

2022-003912-99

A.3

Full title of the trial

Single-blinded randomized investigator-driven controlled trial to assess the efficacy of colchicine to treat patients with cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy)
CMP-MYTHiC – CardioMyoPathy with MYocarditis THerapy with Colchicine

Trial multicentrico randomizzato e controllato in singolo cieco e registro osservazionale sulla valutazione di efficacia della colchicina nel trattamento di pazienti con cardiomiopatia infiammatoria cronica e miocardite
CMP-MYTHiC – CardioMyoPathy with MYocarditis THerapy with Colchicine

A.3.1

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

Study to assess the efficacy of colchicine to treat patients with cardiomyopathy with chronic inflammatory cardiomyopathy and myocarditis.

Studio per valutare l'efficacia della colchicina nel trattamento di pazienti con cardiomiopatia infiammatoria cronica e miocardite.

A.3.2

Name or abbreviated title of the trial where available

CMP-MYTHiC

A.4.1

Sponsor's protocol code number

CMP-MYTHiC

A.5.4

Other Identifiers

Name:

CMP-MYTHiC

Number:

CMP-MYTHiC

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	AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministero della Salute, NextGenerationEU (PNRR-MAD-2022-12376225)
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	ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA
B.5.2	Functional name of contact point	Cardiologia 2 - Insuff.Card e Trap.
B.5.3	Address:
B.5.3.1	Street Address	P.ZZA OSPEDALE MAGGIORE 3
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20162
B.5.3.4	Country	Italy
B.5.4	Telephone number	0264447791
B.5.5	Fax number	0264442566
B.5.6	E-mail	enrico.ammirati@ospedaleniguarda.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.2.1.1.1	Trade name	COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ACARPIA - SERVICOS FARMACEUTICOS LDA
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	COLCHICINA
D.3.2	Product code	[8884]
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	colchicina
D.3.9.1	CAS number	64-86-8
D.3.9.2	Current sponsor code	Merck Index: 12,02536
D.3.9.3	Other descriptive name	COLCHICINE
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy)

Cardiomiopatia infiammatoria cronica e miocardite

E.1.1.1

Medical condition in easily understood language

Cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy)

Cardiomiopatia infiammatoria cronica e miocardite

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	10007636
E.1.2	Term	Cardiomyopathy
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

The primary efficacy will be measured after 6 months of treatment (colchicine vs. placebo). It is expected that patients on optimal medical therapy (OMT) plus colchicine will have a large proportion of positive responses.

L'efficacia primaria sarà misurata dopo 6 mesi di trattamento (colchicina vs. placebo). Si prevede che i pazienti in terapia medica ottimale (OMT) più colchicina avranno una percentuale maggiore di risposte positive.

E.2.2

Secondary objectives of the trial

1.Improvement in left ventricular (LV) ejection fraction (EF) on echocardiogram. Patients not performing the CMRI due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF.
2.Improvement in LVEF on CMRI when available.
3.Lower % of patients with LVEF<55% AND/OR LV dilation on 6-month CMRI or not performing the CMRI due to death, HTx, LVAD implantation or device implantation (i.e. PM or ICD).
4.Composite endpoint:(1) all-cause death or (2) HTx or (3) long-term LVAD implantation, or (5) first rehospitalization due to HF or VA, or advanced atrioventricular (AV) block, within 6 month.
5.All-cause death within 6 months
6.HF/VA or advanced AV block within 6 months
7.Composite endpoint of: NSVT OR increased burden of PVCs (>5% ) on 24-hour ECG ambulatory monitoring, performed at 6- months
8.Changes from baseline to 6 months in quality of life and health assessment
9.Need to initiate an immunosuppressive drug (i.e. corticosteroids)

1. Miglioramento della frazione di eiezione (EF) del ventricolo sinistro (LV) all'ecocardiogramma I pazienti che non eseguono la CMRI a causa di decesso, trapianto di cuore (HTx) saranno conteggiati come -10 punti nella LVEF.
2. Miglioramento della LVEF alla CMRI se disponibile
3. Percentuale inferiore di pazienti con LVEF<55% e//o dilatazione LV alla CMRI a 6 mesi, HTx, impianto di LVAD o impianto di dispositivo dopo la randomizzazione (ad es. PM o ICD).
4. Endpoint composito: tempo tra randomizzazione al primo evento: morte per tutte le cause o (2) HTx o (3) impianto di LVAD o (5) prima riospedalizzazione per HF o VA o blocco atrioventricolare (AV).
5. Mortalità totale a 6 mesi di follow-up
6.Tempo tra randomizzazione e ricovero per HF/VA o blocco AV.
7.Endpoint composito: NSVT o aumento del carico di PVC (>5%) sul Holter delle 24 ore, eseguito a 6 mesi.
8.Cambiamenti nella qualità di vita e stato di salute ai 6 mesi
9.Necessità di trattamento immunosoppressivo (es.corticosteroidi).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients of 18 years or older
2. Evidence of myocardial inflammation on CMRI (using 2018 Lake Louis criteria) or FDG-PET performed in the 3 months before randomization to be included in the trial OR in the last 12 months before for the registry.
3. Presence of any of the following characteristics and if symptoms are present lasting for more than 1 month:
a. Mono-morphic or polymorphic PVC burden of =3000 in 24 hours, or NSVTs (defined as >3 more consecutive beat lasting <30 seconds) or evidence of sustained ventricular tachycardias (SVT).
b. Reduced LVEF on echocardiogram (<50%) or on CMRI (<60%)
c. Increased N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1000 pg/mL or more, or a B-type natriuretic peptide (BNP) concentration of 200 pg/mL or more
d. Persistence of increased high-sensitivity troponin levels above the upper reference limit (URL) after at least 2 months from the first assessment and at least a mono-morphic or polymorphic PVC burden of =1000 in 24 hours

1. Pazienti di età pari o superiore a 18 anni
2. Evidenza di infiammazione miocardica sulla CMRI (secondo i criteri di Lake Louis 2018) o sulla FDG-PET eseguita nei 3 mesi precedenti la randomizzazione da includere nel TRIAL o eseguita nei 12 mesi precedenti il ricovero per il REGISTRY.
3. Presenza di una delle seguenti caratteristiche e se i sintomi sono presenti per più di 1 mese:
a. Burden di extrasistoli ventricolari(PVC) monomorfe o polimorfe =3000 nelle 24 ore, o NSVT (definiti come >3 battiti consecutivi della durata di <30 secondi) o evidenza di tachicardie ventricolari sostenute (SVT).
b. LVEF ridotta all'ecocardiogramma (<50%) o alla CMRI (<60%).
c. Aumento della concentrazione di peptide natriuretico di tipo N-terminale pro-B (NT-proBNP) di 1000 pg/mL o più, o di peptide natriuretico di tipo B (BNP) di 200 pg/mL o più.
d. Persistenza di un aumento dei livelli di troponina ad alta sensibilità al di sopra del limite superiore di riferimento (URL) dopo almeno 2 mesi dalla prima valutazione e almeno un burden di PVC monomorfico o polimorfico =1000 in 24 ore

E.4

Principal exclusion criteria

1.Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,
2. Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,
3. Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy)
4. Known systemic autoimmune disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry.
5. Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
6. Known chronic infective disease, such as HIV infection or tuberculosis
7. Participants involved in another clinical trial;
8. Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age; and breastfeeding women.
9. Any other significant disease or disorder which (expected life expectancy <12 months), in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial.
10. Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction,
11.. Advance heart failure (NYHA III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation,
12.. Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful (i.e. cardiac sarcoidosis),
13. Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary
14. Contraindication to colchicine, including allergies to this medication and its excipients (i.e., lactose and sucrose),
15. Impaired renal function (eGFR<30 ml/min/1.73m2),
16. Known history of hepatic cirrhosis or transaminase levels at baseline > x3-fold the URL
17.Patients with peripheral eosinophilia (eosinophil count >10% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization.

1. Anamnesi accertata di infarto miocardico con evidenza di cicatrice ischemica all'ecocardiogramma o alla CMRI,
2. Malattia coronarica significativa che limita il flusso (stenosi superiore al 50%) all'angiografia coronarica invasiva o all'angiografia coronarica con tomografia computerizzata (TC),
3. Cardiomiopatia attribuita a tossine, come alcol e droghe illecite, o a cause specifiche (ad es. amiloidosi o cardiomiopatia ipertrofica).
4. Disturbo autoimmune sistemico noto (fanno eccezione i pazienti con malattia autoimmune sistemica o sarcoidosi cardiaca isolata con una storia familiare di cardiomiopatia, miocardite o aritmie, in cui può verificarsi una sovrapposizione tra un evento autoimmune e un background genetico). Questi pazienti saranno sottoposti a test genetici. I pazienti con disturbi sistemici autoimmuni e sarcoidosi cardiaca isolata con test genetici positivi per MCVG saranno inclusi nel registro.
5. Precedenti interventi di chirurgia cardiaca, ad esempio per la correzione di una cardiopatia congenita o per la riparazione/sostituzione di una valvola.
6. Malattie infettive croniche note, come l'infezione da HIV o la tubercolosi.
7. Partecipanti coinvolti in un altro studio clinico;
8. Donne incinte (gravidanza nota) o misure POSITIVE del test della gonadotropina corionica umana (HCG) (urina/sangue) per le donne di età compresa tra 18 e 50 anni.
9. Qualsiasi altra malattia o disturbo significativo che (aspettativa di vita prevista <12 mesi), a giudizio dello Sperimentatore, possa mettere a rischio i partecipanti a causa della partecipazione allo studio, o possa influenzare il risultato dello studio o la capacità dei partecipanti di partecipare allo studio.
10. Aritmie atriali sintomatiche in corso (inclusa la fibrillazione atriale persistente) associate a disfunzione LV,
11.. Insufficienza cardiaca avanzata (NYHA III o necessità di inotropi, incluso levosimendan) o VA ricorrente nonostante una precedente ablazione con catetere,
12.. Disturbi autoimmuni sistemici noti o altre condizioni al momento della randomizzazione in cui si presume utile l'immunosoppressione (ad es. sarcoidosi cardiaca),
13.Pazienti già sottoposti a terapie immunosoppressive croniche (compresa la colchicina) o nei quali la terapia immunosoppressiva è ritenuta necessaria
14. Controindicazioni alla colchicina, comprese le allergie a questo farmaco e ai suoi eccipienti (ad es. lattosio e saccarosio),
15. Funzionalità renale compromessa (eGFR<30 ml/min/1,73m2),
16. Anamnesi nota di cirrosi epatica o livelli di transaminasi al basale >3 volte l'URL
17. Pazienti con eosinofilia periferica (conta degli eosinofili >10% dei leucociti) o sindrome ipereosinofila nota al momento della randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

Larger proportion of positive response to treatment will include survival free of clinical worsening, worsening arrhythmic burden, and imaging outcome PLUS ANY of the signs of improvements (IMAGING or ARRHYTMIC improvements).

L'endpoint primario: la risposta positiva al trattamento includerà:
A) La sopravvivenza priva di peggioramento clinico.
B) La sopravvivenza priva di peggioramento del carico aritmico ventricolare.
C) Risultati di imaging cardiaco.
D) QUALSIASI segno di miglioramento (IMAGING o miglioramenti ARITMICI).

E.5.1.1

Timepoint(s) of evaluation of this end point

At 6 months follow-up

Ai 6 mesi di follow-up

E.5.2

Secondary end point(s)

1. Improvement in left ventricular (LV) ejection fraction (EF) on echocardiogram. Patients not performing the CMRI due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF.
2. Improvement in LVEF on CMRI when available. Patients not performing the CMRI due to death, heart transplantation (HTx), LV assist device (LVAD) implantation or device implantation after randomization (i.e. pacemaker [PM] or implantable cardioverter defibrillator [ICD]) will be counted as -10 point in the LVEF.
3. Lower proportion of patients with LVEF<55% AND/OR LV dilation on 6-month CMRI (CMRI clips will be centrally reviewed) or not performing the CMRI due to death, HTx, LVAD implantation or device implantation after randomization (i.e. PM or ICD).
4. Composite endpoint defined as the time from randomization to the first event occurring within 6 months: (1) all-cause death or (2) HTx or (3) long-term LVAD implantation, or (5) first rehospitalization due to HF or VA, or advanced atrioventricular (AV) block.
5. Mortality: time from randomization to all-cause death within 6 months
6. Time from randomization to hospitalization for HF/VA or advanced AV block within 6 months
7. Composite endpoint of presence of NSVT OR increased burden of PVCs (>5% ) on 24-hour ECG ambulatory monitoring, performed at 6- months
8. Changes in quality of life and health assessment at 6 months follow up compared with baseline using 2 different questionnaires: the EuroQoL 5-dimension, 5-level questionnaire (EoQ-5D) and Kansas City Cardiomyopathy Questionnaire (KCCQ – clinical summary scale and overall summary scale).
9. Need to initiate an immunosuppressive drug (i.e. corticosteroids)

Miglioramento della frazione di eiezione (EF) del ventricolo sinistro (LV) all'ecocardiogramma. I pazienti che non eseguono la CMRI a causa di decesso, trapianto di cuore (HTx) saranno conteggiati come -10 punti nella LVEF.
2. Miglioramento della LVEF alla CMRI, se disponibile. I pazienti che non eseguono la CMRI a causa di decesso, trapianto di cuore (HTx), impianto di un dispositivo di assistenza LV (LVAD) o impianto di un dispositivo dopo la randomizzazione (ad es. pacemaker [PM] o defibrillatore cardioverter impiantabile [ICD]) saranno conteggiati come -10 punti nella LVEF.
3. Percentuale inferiore di pazienti con LVEF<55% E/O dilatazione LV alla CMRI a 6 mesi (le clip della CMRI saranno esaminate a livello centrale) o mancata esecuzione della CMRI a causa di decesso, HTx, impianto di LVAD o impianto di dispositivo dopo la randomizzazione (ad es. PM o ICD).
4. Endpoint composito definito come il tempo trascorso dalla randomizzazione al primo evento verificatosi entro 6 mesi: (1) morte per tutte le cause o (2) HTx o (3) impianto di LVAD a lungo termine o (5) prima riospedalizzazione per HF o VA o blocco atrioventricolare (AV) avanzato.
5. Mortalità: tempo trascorso dalla randomizzazione alla morte per tutte le cause entro 6 mesi.
6. Tempo dalla randomizzazione al ricovero per HF/VA o blocco AV avanzato entro 6 mesi.
7. Endpoint composito di presenza di NSVT O aumento del carico di PVC (>5%) sul monitoraggio ambulatoriale ECG delle 24 ore, eseguito a 6 mesi.
8. Cambiamenti nella qualità della vita e nella valutazione dello stato di salute a 6 mesi di follow-up rispetto al basale, utilizzando 2 diversi questionari: il questionario EuroQoL a 5 dimensioni e 5 livelli (EoQ-5D) e il Kansas City Cardiomyopathy Questionnaire (KCCQ - scala di sintesi clinica e scala di sintesi generale).
9. Necessità di iniziare un trattamento immunosoppressivo (ad es. corticosteroidi).

E.5.2.1

Timepoint(s) of evaluation of this end point

At 6 months follow-up

Ai 6 mesi di follow-up

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

E.6.4

Safety

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

E.8.1.3

Single blind

Yes

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

Yes

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

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

LPLV

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Standard of care will be applied until 6 month follow-up.

I soggetti verranno seguito come da normale pratica clinica fino ai 6 mesi dalla randomizzazione

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

2023-05-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-05-09

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

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Clinical trials