Clinical Trials Register

Summary
EudraCT Number:	2019-002946-19
Sponsor's Protocol Code Number:	1245-0204
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:	2021-06-15
Trial results	View 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-002946-19

A.3

Full title of the trial

A multicentre, randomised, double-blind, 90-day superiority trial to evaluate the effect on clinical benefit, safety and tolerability of once daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd (EMPULSE)

Studio clinico di superiorità multicentrico, randomizzato, in doppio cieco, della durata di 90 giorni volto a valutare l’effetto in termini di benefici clinici, sicurezza e tollerabilità, di EMPagliflozin 10 mg una volta al giorno per via orale rispetto al placebo, iniziato nei pazienti ricoverati per insufficienza cardiaca acuta (acUte heart faiLure) (de novo o insufficienza cardiaca cronica scompensata) che sono stati stabilizzati (StabilisEd) (EMPULSE)

A.3.1

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

A study to test the effect of empagliflozin in patients who are in hospital for acute heart failure

Studio volto a valutare l’effetto di empagliflozin in pazienti ricoverati per insufficienza cardiaca acuta

A.3.2

Name or abbreviated title of the trial where available

EMPULSE

A.4.1

Sponsor's protocol code number

1245-0204

A.5.4

Other Identifiers

Name:

Number:

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	BOEHRINGER-INGELHEIM ITALIA S.P.A.
B.1.3.4	Country	Italy
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	BOEHRINGER-INGELHEIM ITALIA S.P.A.
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	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	CT Disclosure and Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	0018002430127
B.5.5	Fax number	0018008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	Yes
D.2.1.1.1	Trade name	JARDIANCE
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Empagliflozin
D.3.2	Product code	[-]
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	EMPAGLIFLOZIN
D.3.9.1	CAS number	864070-44-0
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB35915
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	10
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated 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

Heart Failure

insufficienza cardiaca acuta

E.1.1.1

Medical condition in easily understood language

Heart Failure

insufficienza cardiaca acuta

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	10019279
E.1.2	Term	Heart failure
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 assess whether in-hospital administration of empagliflozin results
in improvements in HF-related clinical events and patient-reported
outcomes (death, HFE and KCCQ-TSS as a measure of health status
(symptoms)) in patients hospitalised for acute heart failure (de novo or
decompensated chronic HF) and after initial stabilisation.

L’obiettivo principale di questo studio è pertanto valutare se la somministrazione di empagliflozin durante il ricovero determini un miglioramento degli outcome correlati all’insufficienza cardiaca: benefici clinici in termini anche di morte, eventi di insufficienza cardiaca (HFE) e impatto dei sintomi in base al punteggio del Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) nei pazienti ricoverati per insufficienza cardiaca acuta (de novo o insufficienza cardiaca cronica scompensata) e dopo una stabilizzazione iniziale

E.2.2

Secondary objectives of the trial

To further assess whether it is safe to start empagliflozin in patients
admitted to hospital in this setting

Gli obiettivi secondati sono un’ulteriore valutazione dell’opportunità di iniziare una terapia a base di empagliflozin nei pazienti ricoverati con questo quadro clinico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Currently hospitalised for the primary diagnosis of acute heart failure
(de novo or decompensated chronic HF), regardless of ejection fraction
(EF). Patients with a diagnosis of hospitalized heart failure must have HF
symptoms at the time of hospital admission
2. Evidence of left ventricular ejection fraction (LVEF, either reduced or
preserved EF) as per local reading preferably measured during current
hospitalisation or in the 12 months prior to randomisation
3. Patients must be randomised after at least 24 hours and no later than
5 days after admission, as early as possible after stabilization and while
still in hospital
4. Patients must fulfil the following stabilisation criteria (while in the
hospital):
- SBP =100mm Hg and no symptoms of hypotension in the preceding 6
hours,
- no increase in i.v. diuretic dose for 6 hours prior to randomisation,
- no i.v. vasodilators including nitrates within the last 6 hours prior to
randomisation
- no i.v. inotropic drugs for 24 hours prior to randomisation.
5. Elevated NT-proBNP = 1600pg/mL or BNP =400 pg/mL according to
the local lab, for patients without atrial fibrillation (AF); or elevated NT
proBNP = 2400pg/mL or BNP =600 pg/mL for patients with AF,
measured during the current hospitalization or in the 72 hours prior to
hospital admission,. For patients treated with an angiotensin receptor
neprilysin inhibitor (ARNI) in the previous 4 weeks prior to
randomisation, only NT-proBNP values should be used
6. HF episode leading to hospitalisation must have been treated with a
minimum dose of 40 mg of i.v. furosemide (or equivalent i.v. loop
diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
7. Further Inclusion Criteria Apply

1 Pazienti di età >=18 anni allo screening che hanno firmato e datato il consenso informato in accordo alle ICH-GCP e alle normative vigenti
2 Pazienti ricoverati per diagnosi primaria di insufficienza cardiaca acuta (de novo o cronica scompensata), indipendentemente dalla frazione di eiezione (EF). I pazienti con diagnosi di insufficienza cardiaca da ricovero in ospedale devono avere i sintomi dell’HF al momento del ricovero.
3 Pazienti con frazione di eiezione ventricolare sinistra (LVEF, EF preservata o ridotta) in base ai risultati del laboratorio locale ottenuti tramite misurazioni condotte preferibilmente durante il ricovero attuale o nei 12 mesi precedenti la randomizzazione.
4 I pazienti devono essere randomizzati dopo almeno 24 ore e non oltre 5 giorni dopo il ricovero, non appena possibile dopo la stabilizzazione e mentre sono ancora in ospedale.
5 I pazienti devono soddisfare i seguenti criteri di stabilizzazione (mentre sono in ospedale):
- SBP >=100 mmHg e nessun sintomo di ipotensione nelle 6 ore precedenti,
- nessun aumento della dose di diuretico ev per 6 ore prima della randomizzazione,
- nessun vasodilatatore ev inclusi i nitrati nelle ultime 6 ore prima della randomizzazione,
- nessun farmaco inotropo ev per 24 ore prima della randomizzazione.
6 Pazienti con livello elevato di NT-proBNP >=1600 pg/mL o BNP >= 400 pg/mL in base al laboratorio locale, per i pazienti senza fibrillazione atriale (AF); o livello elevato di NT-proBNP >= 2400 pg/mL o BNP >= 600 pg/mL per i pazienti con AF, misurata durante il ricovero attuale o nelle 72 ore precedenti il ricovero. Per i pazienti trattati con un inibitore del recettore dell’angiotensina e della neprilisina (ARNI) nelle 4 settimane precedenti la randomizzazione, devono essere utilizzati solo i valori NT-proBNP
7 I pazienti con un episodio di HF che ha portato al ricovero ospedaliero devono essere stati trattati con una dose minima di 40 mg di furosemide ev (o diuretico dell’ansa ev equivalente consistente in 20 mg di torasemide o 1 mg di bumetanide).

E.4

Principal exclusion criteria

1. Cardiogenic shock
2. Current hospitalisation for acute heart failure primarily triggered by
pulmonary embolism, cerebrovascular accident, or acute myocardial
infarction (AMI)
3.Current hospitalisation for acute heart failure not caused primarily by
intravascular volume overload;
4. Below interventions in the past 30 days prior to randomisation or
planned during the study:
- Major cardiac surgery, or TAVI (Transcatheter Aortic Valve
Implantation), or PCI, or Mitraclip
- All other surgeries that are considered major according to investigator
judgement
- Implantation of cardiac resynchronisation therapy (CRT) device
- cardiac mechanical support implantation
- Carotid artery disease revascularisation (stent or surgery)
5. Acute coronary syndrome / myocardial infarction, stroke or transient
ischemic attack (TIA) in the past 90 days prior to randomisation
6. Heart transplant recipient, or listed for heart transplant with
expectation to receive a transplant during the course of this trial
(according to investigator judgement), or planned for palliative care for
HF, or currently using left ventricular assist device (LVAD) or intra-aortic
balloon pump (IABP) or any other type of mechanical circulatory
support, or patients on mechanical ventilation, or patients with planned
inotropic support in an outpatient setting
7. Haemodynamically significant (severe) uncorrected primary cardiac
valvular disease planned for surgery or intervention during the course of
the study (note: secondary mitral regurgitation or tricuspid regurgitation
due to dilated cardiomyopathy is not excluded unless planned for
surgery or intervention during the course of the study)
8. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as
measured during hospitalization (latest local lab measurement before
randomisation) or requiring dialysis
9. Type 1 Diabetes Mellitus (T1DM)
10. History of ketoacidosis, including diabetic ketoacidosis (DKA)
11. Further Exclusion Criteria Apply

1 Pazienti con shock cardiogeno
2 Pazienti attualmente ricoverati per insufficienza cardiaca acuta avente come causa scatenante primaria un’embolia polmonare, un accidente cerebrovascolare o un infarto miocardico acuto (AMI)
3 Pazienti attualmente ricoverati per insufficienza cardiaca acuta non avente come causa scatenante primaria un sovraccarico di volume intravascolare;
4 Pazienti sottoposti ad interventi nei 30 giorni precedenti la randomizzazione o per i quali si prevede un intervento durante lo studio:
- Intervento di cardiochirurgia maggiore o TAVI (impianto valvolare aortico transcatetere), o PCI, o Mitraclip
- Tutti gli altri interventi chirurgici considerati maggiori a giudizio dello sperimentatore
- Impianto di un dispositivo per la terapia di resincronizzazione cardiaca (CRT)
- Impianto di un supporto cardiaco meccanico
- Rivascolarizzazione dell’arteria carotide (posizionamento di stent o intervento chirurgico)
5 Pazienti con sindrome coronarica acuta/infarto miocardico, ictus o attacco ischemico transitorio (TIA) nei 90 giorni precedenti la randomizzazione.
6 Pazienti che hanno ricevuto un trapianto cardiaco o che siano in lista per riceverlo, con la probabilità che l’intervento si svolga durante lo studio (in base al giudizio dello sperimentatore) o per i quali siano programmate cure palliative per l’HF, o che attualmente utilizzano un dispositivo di assistenza ventricolare sinistra (LVAD) o una pompa intra-aortica a palloncino (IABP) o qualsiasi altro tipo di supporto circolatorio meccanico, oppure i pazienti in ventilazione meccanica o per i quali sia prevista una terapia di supporto con un farmaco inotropo in un contesto ambulatoriale.
7 Pazienti con valvulopatia cardiaca primaria significativa (grave) dal punto di vista emodinamico e non corretta per la quale sia programmato un intervento chirurgico durante lo studio (nota: un rigurgito mitralico o un rigurgito tricuspidale secondari dovuti a cardiomiopatia dilatativa non costituiscono fattori di esclusione, salvo il caso in cui sia programmato un intervento chirurgico nel corso dello studio).
8 Pazienti con compromissione della funzionalità renale, consistente in eGFR <20 mL/min/1.73 m2 secondo le misurazioni condotte durante il ricovero (ultima misurazione del laboratorio locale prima della randomizzazione) o che necessitino di dialisi.
9 Pazienti con diabete mellito di tipo 1 (T1DM).
10 Pazienti con anamnesi di chetoacidosi, inclusa chetoacidosi diabetica (DKA).

E.5 End points

E.5.1

Primary end point(s)

1. Clinical benefit, a composite of death, number of heart failure events
(HFE) (including hospitalisations for heart failure (HHFs), urgent heart
failure visits and unplanned outpatient visits), time to first HFE and
change from baseline in KCCQ-TSS after 90 days of Treatment assessed
by the win ratio.

1) L’endpoint primario è dato dal beneficio clinico, un parametro composito di morte, numero di eventi di insufficienza cardiaca (HFE) (inclusi i ricoveri per insufficienza cardiaca (HHF), visite mediche per insufficienza cardiaca urgenti e visite ambulatoriali non programmate), tempo al primo HFE e variazione rispetto al basale nel Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) dopo 90 giorni di trattamento valutato con il win ratio.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Baseline and after 90 days of treatment

1) basale e dopo 90 giorni di trattamento.

E.5.2

Secondary end point(s)

1. Improvement in KCCQ-TSS of = 10 points
2. Change from baseline in KCCQ-TSS after 90 days of treatment.
3. Change from baseline in log-transformed N-Terminal Pro-Brain
Natriuretic Peptide (NTproBNP) level over 30 days of treatment (area
under the curve (AUC)).
4. Days alive and out of hospital from study drug initiation until 30 days
after initial hospital discharge.
5. Days alive and out of hospital from study drug initiation until 90 days
after randomisation.
6. Time to first occurrence of CV death or HFE until end of trial visit.
7. Occurrence of HHF until 30 days after initial hospital discharge.
8. Occurrence of chronic dialysis or renal transplant or sustained
reduction of =40% eGFR Chronic Kidney Disease Epidemiology
Collaboration Equation ((CKD-EPI)cr), or
-sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for patients with
baseline eGFR =30 mL/min/1.73 m2
-sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with
baseline eGFR <30 mL/min/1.73 m2
9. Diuretic effect as assessed by weight loss per mean daily loop diuretic
dose after 15 days of treatment.
10. Diuretic effect as assessed by weight loss per mean daily loop
diuretic dose after 30 days of treatment.

1)Miglioramento nel KCCQ-TSS, pari a >10 punti, dopo 90 giorni di trattamento
2)Variazione rispetto al basale nel KCCQ-TSS dopo 90 giorni di trattamento
3) Variazione rispetto al basale del livello pro-BNP N-terminale trasformato in log su 30 giorni di trattamento (area sotto la curva (AUC)).
4) Giorni in vita e fuori dall’ospedale dall’inizio della terapia fino a 30 giorni dopo la dimissione dall’ospedale
5) Giorni in vita e fuori dall’ospedale dall’inizio della terapia fino a 90 giorni dopo la randomizzazione
6) Tempo alla prima occorrenza di morte cardiovascolare (CV) o HFE fino alla visita di fine dello studio
7) Verificarsi di HHF fino a 30 giorni dopo la dimissione dall’ospedale
8) Verificarsi di dialisi cronica o di trapianto renale o riduzione prolungata nel tempo di >40% del tasso stimato di filtrazione glomerulare (eGFR) secondo la Chronic Kidney Disease Epidemiology Collaboration Equation ((CKD-EPI)cr), oppure eGFR (CKD-EPI)cr prolungata nel tempo <15 mL/min/1.73 m2 per i pazienti con eGFR basale >30 mL/min/1.73 m2 o eGFR (CKD-EPI)cr prolungata nel tempo <10 mL/min/1.73 m2 per i pazienti con eGFR basale <30 mL/min/1.73 m2
9) Effetti diuretici valutati in base al calo di peso per dose giornaliera media di diuretico dell’ansa dopo 15 giorni di trattamento
10 )Effetti diuretici valutati in base al calo di peso per dose giornaliera media di diuretico dell’ansa dopo 30 giorni di trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After 90 days of treatment
2. Baseline and after 90 days of treatment
3. Baseline and after 30 days of treatment
4. 30 days after initial hospital discharge
5. 90 days after randomisation
6. End of Trial Visit (day 90 or 97 after randomisation)
7. 30 days after initial hospital discharge
8. End of Trial Visit (day 90 or 97 after randomisation)
9. After 15 days of treatment
10. After 30 days of treatment

1) dopo 90 giorni di trattamento
2) al basale e dopo 90 giorni di trattamento
3) Variazione rispetto al basale 30 giorni.
4) 30 giorni dopo la dimissione dall’ospedale
5) 90 giorni dopo la randomizzazione
6) fino alla visita di fine dello studio
7) 30 giorni dopo la dimissione dall’ospedale
8) Visita di fine studio
9) 15 giorni di trattamento
10) 30 giorni di trattamento

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)

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

E.8.1.4

Double blind

Yes

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

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

Canada

China

Japan

United States

Belgium

Denmark

Germany

Hungary

Italy

Netherlands

Norway

Poland

Spain

Sweden

Czechia

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

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

415

F.4.2.2

In the whole clinical trial

500

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)

Patients will continue with standard medical care. Patients receive SOC
during study and will continue. Study medicaiton is on top

I pazienti continueranno la loro terapia standard

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

2020-03-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-03-24

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials