Clinical Trials Register

Summary
EudraCT Number:	2019-003514-14
Sponsor's Protocol Code Number:	CL2-62798-010
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-10
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-003514-14

A.3

Full title of the trial

A Multicentre, Randomized, Double-blind, Placebo-controlled Dose-finding Study of S62798 in Patients with Intermediate-High Risk Acute Pulmonary Embolism on heparin

Studio multicentrico, randomizzato, a doppio cieco, controllato con placebo per la determinazione del dosaggio di S62798 in pazienti con embolia polmonare acuta a rischio medio-alto in trattamento con eparina

A.3.1

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

A study to find the appropriate dose of S62798 to treat patients with pulmonary circulation blocked by a clot

Studio per determinare il dosaggio appropriato di S62798 per il trattamento di pazienti con circolazione polmonare bloccata da un coagulo

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CL2-62798-010

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	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
B.1.3.4	Country	France
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	ADIR
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Istituto di Ricerca Servier s.r.l.
B.5.2	Functional name of contact point	Project manager: Chiara PERTICA
B.5.3	Address:
B.5.3.1	Street Address	Via Luca Passi, 85
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00166
B.5.3.4	Country	Italy
B.5.4	Telephone number	003906669081
B.5.5	Fax number	00390666908738
B.5.6	E-mail	clinicaltrials@servier.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S62798
D.3.2	Product code	[S62798]
D.3.4	Pharmaceutical form	Concentrate 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	S62798
D.3.9.2	Current sponsor code	S62798
D.3.9.4	EV Substance Code	SUB184588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1
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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S62798
D.3.2	Product code	[S62798]
D.3.4	Pharmaceutical form	Concentrate 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	S62798
D.3.9.2	Current sponsor code	S62798
D.3.9.4	EV Substance Code	SUB184588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1
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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S62798
D.3.2	Product code	[S62798]
D.3.4	Pharmaceutical form	Concentrate 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	S62798
D.3.9.2	Current sponsor code	S62798
D.3.9.4	EV Substance Code	SUB184588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1
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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S62798
D.3.2	Product code	[S62798]
D.3.4	Pharmaceutical form	Concentrate 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	S62798
D.3.9.2	Current sponsor code	S62798
D.3.9.4	EV Substance Code	SUB184588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2
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	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute intermediate high risk pulmonary embolism (PE)

Embolia polmonare acuta a rischio medio-alto (EP)

E.1.1.1

Medical condition in easily understood language

Pulmonary circulation blocked by a clot

Circolazione polmonare bloccata da un coagulo

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10037377
E.1.2	Term	Pulmonary embolism
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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 determine the dose-response relationship of S62798 on the RV/LV end-diastolic diameter (EDD) 24h after treatment initiation, in patients with intermediate-high risk pulmonary embolism (PE) on heparin.

Stabilire la relazione dose-risposta di S62798 sul diametro telediastolico (EDD) del VD/VS 24h ore dopo l’inizio del trattamento, in pazienti con embolia polmonare (EP) a rischio medio-alto in trattamento con eparina.

E.2.2

Secondary objectives of the trial

To assess the effect of S62798 on secondary efficacy endpoints such as TAPSE, and PE-related clinical events.
To assess the safety profile of S62798 in the study population.
To assess the pharmacokinetics of S62798 (and metabolites if applicable).

Valutare l’effetto di S62798 su endpoint secondari di efficacia quali TAPSE, e eventi clinici legati a EP.
Valutare il profilo di sicurezza di S62798 nella popolazione dello studio.
Valutare la farmacocinetica di S62798 (e i metaboliti ove applicabile).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Acute pulmonary embolism and categorized as intermediate-high risk and documented by CT pulmonary angiography (CTPA), V/Q scan, V/Q SPECT or pulmonary angiography with emboli in at least one segmental or more proximal artery
2. Troponin I or high sensitivity Troponin T elevated as per local lab
3. Evidence of right ventricular dysfunction (RVD) on echocardiography or CTPA
4. With at least one of the following clinical criteria:
- SBP lower than 110 mmHg for > 15 min or,
- Respiratory rate > 20 per min or SaO2 < 90% on room air or,
- Sinus tachycardia >= 110 bpm sustained over 30 seconds.

1. Embolia polmonare acuta classificata come a rischio medio-alto documentata con angiografia polmonare TAC (CTPA), V/Q scan, V/Q SPECT o angiografia polmonare con emboli in almeno una arteria segmentale o più prossimale
2. Livello elevato di Troponina I o Troponina T ad elevata sensibilità secondo laboratorio locale.
3. Evidenza di disfunzionalità ventricolare destra DVD in ecocardiografia o CTPA
4. Con almeno uno dei seguenti criteri clinici:
- SBP inferiore a 110 mmHg per > 15 min oppure
- Ritmo respiratorio > 20 per min o SaO2 < 90% a temperatura ambiente oppure
- Tachicardia sinusale >= 110 bpm sostenuta per oltre 30 secondi.

E.4

Principal exclusion criteria

1. Presence of right heart thrombus
2. Reperfusion therapy planned.
3. Patients with forbidden previous or concomitant treatment
4. Known or pre-existing chronic pulmonary hypertension
5. Uncontrolled hypertension defined as SBP>180 mm Hg and/or DBP >110 mm Hg
6. Patients with a high risk of haemorrhage
7. Patients with less than 3 months of life expectancy
8. Platelet count lower than 100 G/L (100 000 platelets/µL), INR above 1.5 or abnormal aPTT not explained by concomitant anticoagulation therapy
9. Positive results of pregnancy test or lacting women

1. Presenza di trombo/i nel ventricolo destro
2. Terapia di riperfusione programmata
3. Pazienti sottoposti a trattamento precedente o concomitante proibito
4. Ipertensione polmonare cronica nota o preesistente
5. Ipertensione non controllata definita come PAS>180 mm Hg e/o PAD >110 mm Hg
6. Pazienti ad elevato rischio di emorragia
7. Pazienti con aspettativa di vita inferiore a 3 mesi.
8. Conta delle piastrine inferiore a 100 G/L (100.000 piastrine/µL), INR sopra 1,5 o aPTT anomalo non spiegato da concomitante terapia anticoagulante.
9. Risultati positivi al test di gravidanza o donna in allattamento.

E.5 End points

E.5.1

Primary end point(s)

Right /left ventricular end-diastolic diameter (RV/LV EDD)

Variazione del diametro telediastolico ventricolare destro/sinistro (EDD VD/VS).

E.5.1.1

Timepoint(s) of evaluation of this end point

24h (±2h) after treatment initiation

24h (+/- 2h dopo l’inizio dell’infusione)

E.5.2

Secondary end point(s)

1. RV/LV EDD
2. Tricuspid annular plane systolic excursion (TAPSE) estimated by echocardiography
3. Adjudicated PE-related clinical events
4. Pharmacokinetic measurements

1 - diametro telediastolico ventricolare destro/sinistro (EDD VD/VS),
2 - escursione sistolica del piano dell'anello tricuspidale (TAPSE) stimata mediante ecocardiografia,
3 - eventi clinici legati all’EP
4 - rilevamenti farmacocinetici

E.5.2.1

Timepoint(s) of evaluation of this end point

1. For RV/LV EDD: 48h (±4h) and 30d (±2d)
2. For tricuspid annular plane systolic excursion (TAPSE) estimated by echocardiography: 24h (±2h), 48h (±4h) and 30d (±2d)
3. For adjudicated PE-related clinical events: Between baseline and day 30
4. For pharmacokinetic measurements: Between baseline and day 6

1 - diametro telediastolico ventricolare destro/sinistro (EDD VD/VS) dopo 48h (+/-4h) e dopo 30 giorni (+/- 2gg)
2 - escursione sistolica del piano dell'anello tricuspidale (TAPSE) stimata mediante ecocardiografia: dopo 24h (+/-2h) , 48h (+/-4h) e dopo 30 giorni (+/- 2gg)
3 - eventi clinici legati all’EP: alla visita baseline e dopo 30 giorni
4 - rilevamenti farmacocinetici: alla visita baseline e dopo 6 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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

Argentina

Austria

Belgium

Brazil

Czechia

Estonia

Finland

Germany

Greece

Hungary

Israel

Italy

Japan

Korea, Republic of

Latvia

Lithuania

Poland

Portugal

Romania

Russian Federation

Slovakia

South Africa

Spain

Taiwan

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

End of Trial is defined as the date of the last follow-up of the last participant, or the date of the last contact attempt if the last participant is declared lost to follow-up.

La fine dello studio si definisce come la data dell'ultima visita di follow up dell'ultimo partecipante o la data dell'ultimo tentativo di contatto, se l'ultimo partecipante fosse dichiarato "perso al follow up".

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:

185

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

185

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

258

F.4.2.2

In the whole clinical trial

370

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)

The participants' treatment is left to the physician's discretion. As the study drug is not licensed yet at this time, it will not be available on the market.

La scelta del trattamento per ogni partecipante è lasciata al giudizio clinico del medico. Poiché il farmaco non è autorizzato al momento, non sarà disponibile in commercio

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

2020-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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