Clinical Trials Register

Summary
EudraCT Number:	2020-000996-19
Sponsor's Protocol Code Number:	MAA-304
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:	2021-05-24
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

2020-000996-19

A.3

Full title of the trial

Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On-Demand Treatment and Control of Bleeding Episodes in Subjects with Haemophilia A or Haemophilia B, with Inhibitors: The Crimson 1 Study

Studio di fase 3 teso a valutare l'efficacia e la sicurezza di Marzeptacog Alfa (attivato) a somministrazione sottocutanea per il trattamento on-demand e il controllo di episodi di sanguinamento in soggetti affetti da emofilia A o emofilia B, con inibitori: Studio Crimson 1

A.3.1

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

Study to evaluate the efficacy and safety of MarzAA for the control of bleeding episodes in subjects with Haemophilia A or Haemophilia B, with Inhibitors

Studio per valutare l'efficacia e la sicurezza di MarzAA nel controllo di episodi di sanguinamento in soggetti affetti da emofilia A o emofilia B, con inibitori

A.3.2

Name or abbreviated title of the trial where available

The Crimson 1 Study

Lo studio Crimson 1

A.4.1

Sponsor's protocol code number

MAA-304

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	Catalyst Biosciences, Inc.
B.1.3.4	Country	United States
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	Catalyst Biosciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Catalyst Biosciences, Inc.
B.5.2	Functional name of contact point	Dr. Linda Neuman
B.5.3	Address:
B.5.3.1	Street Address	611 Gateway Blvd., Suite 710
B.5.3.2	Town/ city	South San Francisco, California
B.5.3.3	Post code	94080
B.5.3.4	Country	United States
B.5.4	Telephone number	+16502668667
B.5.5	Fax number	+16508712475
B.5.6	E-mail	lneuman@catbio.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/19/2151 for MarzAA (Haemophilia B only)
D.3 Description of the IMP
D.3.1	Product name	Marzeptacog alfa (activated)
D.3.2	Product code	[MarzAA or CB813d]
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Marzeptacog alfa (activated)
D.3.9.1	CAS number	1600492-21-4
D.3.9.2	Current sponsor code	MarzAA or CB813d
D.3.9.4	EV Substance Code	SUB13812MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4600
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)	Yes
	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	Yes
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

Marzeptacog alfa (activated) (MarzAA), a novel activated recombinant Factor VII (rFVIIa) variant, is being developed by Catalyst Biosciences to address the unmet need in haemophilia and other bleeding disorders.

Marzeptacog alfa (attivato) (MarzAA), una nuova variante del Fattore VII ricombinante attivato (rFVIIa), è stato sviluppato da Catalyst Biosciences per rispondere alle esigenze non ancora soddisfatte dell'emofilia e di altri disordini della coaugulazione.

E.1.1.1

Medical condition in easily understood language

Haemophilia and other bleeding disorders

Emofilia e altri disordini della coaugulazione.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

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	10066439
E.1.2	Term	Hemophilia
E.1.2	System Organ Class	100000004850

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of MarzAA for the on-demand treatment and control of bleeding episodes at 24 hours after the initial dose

Valutare l'efficacia di MarzAA per il trattamento on-demand e il controllo di episodi di sanguinamento nell'arco di 24 ore dopo la dose iniziale

E.2.2

Secondary objectives of the trial

• To determine the time needed to achieve haemostasis after the initial dose
• To assess the ability of MarzAA to achieve and maintain haemostasis in the treatment of bleeds at fixed timepoints after the initial dose
• To assess the number of doses and the cumulative dose needed to achieve adequate haemostasis for individual bleeds
• To assess the percentage of bleeds with treatment success at 24 hours that maintain haemostatic efficacy at 48 hours after the initial dose
• To assess the use and amount of rescue therapy required
• To assess the subcutaneous population PK of MarzAA

• Stabilire il tempo necessario per ottenere l'emostasi dopo la dose iniziale
• Valutare la capacità di MarzAA di ottenere e mantenere l'emostasi nel trattamento di sanguinamenti a punti temporali stabiliti, dopo la dose iniziale
• Valutare il numero di dosi e la dose cumulativa necessarie per ottenere un'adeguata emostasi per i sanguinamenti individuali
• Valutare la percentuale di sanguinamenti con successo di trattamento a 24 ore che mantengono l'efficacia emostatica a 48 ore dopo la dose iniziale
• Valutare l’uso e la quantità di terapia di salvataggio
• Valutare la farmacocinetica della popolazione (PopPK) trattata con MarzAA somministrato per via sottocutanea

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Confirmed diagnosis of congenital HA or HB, with inhibitors, with confirmation of one of the following:
a) Titer of =5BU
b) Titer of =0.6 BU but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the subject’s medical history, precluding the use of FVIII or FIX products to treat bleeding as documented by the Investigator
c) Titer =0.6 BU but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the subject’s medical history, precluding the use of FVIII or FIX products to treat bleeding as documented by the Investigator
Note: Documentation of highest historic titer should be recorded.
2) History of bleeding with an ABR of =8
3) Male or Female, =12 years of age
4) Agreement to use highly effective birth control throughout the study if the subject has childbearing potential
5) If female, then the subject must meet the following criteria:
a) Not currently be breastfeeding
b) Not plan on becoming pregnant during the study
c) Be surgically sterile, or at least 2-years postmenopausal, or have a negative serum pregnancy test at Screening (Visit 1)
6) Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 years before any study related activities
Note: study related activities are any procedure that would not have been performed during normal clinical management of the subject
7) Stated willingness to comply with all study procedures and availability for the duration of the study
8) Investigator-confirmed subject’s ability to rapidly assess a bleeding episode and respond appropriately
9) Investigator-confirmed subject’s ability to administer MarzAA SC and infuse SOC at home

1) Diagnosi confermata di HA o HB congenita con inibitori, con conferma di uno dei seguenti parametri:
a) Titolo = 5 BU
b) Titolo =0,6 BU ma con una prevista alta risposta anamnestica a FVIII o FIX, come dimostrato dall'anamnesi del soggetto, che preclude l'utilizzo di prodotti a base di FVIII o FIX per trattare episodi di sanguinamento come documentato dallo Sperimentatore.
c) Titolo =0,6 BU ma con una prevista refrattarietà a dosaggi crescenti di FVIII o FIX, come dimostrato dall'anamnesi del soggetto che preclude l'utilizzo di prodotti a base di FVIII o FIX per trattare episodi di sanguinamento, come documentato dallo sperimentatore
Nota: i dati relativi ai titoli storici più alti dovrebbero essere registrati.
2) Anamnesi di sanguinamento con un ABR =8
3) Sesso maschile o femminile, età =12 anni
4) Consenso a utilizzare un metodo di controllo delle nascite altamente efficace per tutto il periodo dello studio se il soggetto è in età fertile
5) I soggetti di sesso femminile devono soddisfare i seguenti criteri:
a) Devono astenersi dall'allattamento al seno
b) Devono astenersi dal programmare una gravidanza durante il corso dello studio
c) Devono essere sterilizzate chirurgicamente, essere in menopausa da almeno 2 anni o avere un test di gravidanza su siero risultato negativo allo screening (Visita 1)
6) Firma del modulo di consenso informato e assenso per ragazzi di età compresa tra 12 e 17 anni prima di partecipare a qualsiasi attività correlata allo studio
Nota: per attività correlata allo studio si intende qualsiasi procedura che non sarebbe eseguita durante la normale gestione clinica del soggetto
7) Dichiarazione della propria volontà di aderire a tutte le procedure dello studio ed essere disponibili nel corso dello studio
8) Capacità del soggetto, comprovata dallo sperimentatore, di valutare rapidamente un episodio di sanguinamento e rispondere in modo appropriato
9) Capacità del soggetto, comprovata dallo sperimentatore di somministrare MarzAA per via sottocutanea e infondere il SOC presso la propria abitazione

E.4

Principal exclusion criteria

1) Previous participation in a study involving SC administration of rFVIIa (NovoSeven or MOD-5014) or any study using a modified amino-acid sequence FVIIa (other than MarzAA) such as: NN1731 or BAY86-6150. Prior participation in a study of intravenous (IV) LR769, rFVIIa-FP (CSL689), or MarzAA is permissible
2) Previous participation in a clinical study with subsequent treatment within the previous 30 days or =5-half-lives or absence of clinical effect, whichever is longer
3) Known positive antibody to FVIIa or variants thereof detected during screening and prior to Day 1
4) Known hypersensitivity to pd-FVIIa, pd-FVII, wt rFVIIa or MarzAA or any of the excipients or related products
5) Treatment with anticoagulants or antiplatelet therapy within one week of enrollment or anticipated need during the study
6) Planned elective surgery within 12 months following study entry
7) History of other clinically relevant coagulation disorder(s)
8) Platelet count <50,000 /µL based on screening laboratory assessments
9) Current or history of advanced atherosclerotic disease (ie, known history of coronary artery disease [CAD], ischemic stroke, etc.), or deep venous thrombosis (DVT) or pulmonary emobolism (PE) within 24 months of dosing or considered to be at a high risk of venous thromboembolic event (VTE) as judged by the Investigator
10) CD 4 T Cell count of <200 cells/ mm3
11) Compromised hepatic or renal function:
a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels =5 × the upper limit of normal (ULN)
b) Total bilirubin (TBIL) level =2 mg/dL (>35 µmol/L) unless there is a known history of Gilbert’s syndrome (GS)
c) Serum creatinine (Cr) level >1.25 × ULN
12) Inability or medical, psychosocial, or familial issues that might prevent full participation and cooperation with the procedures and requirements of the clinical study as determined by the potential subject and Investigator
13) Weight =105 kg (231 lbs.)

1) Precedente partecipazione a uno studio che prevede la somministrazione per via sottocutanea di rFVIIa (NovoSeven o MOD-5014) o qualsiasi studio in cui si utilizza FVIIa a sequenza amminoacidica modificata (diverso dal MarzAA), quale: NN1731 o BAY86-6150. Una precedente partecipazione a uno studio in cui si utilizza LR769 per via endovenosa, rFVIIa-FP (CSL689) o MarzAA è permessa.
2) Precedente partecipazione a uno studio clinico con successivo trattamento entro i 30 giorni precedenti o =5 emivite o assenza dell'effetto clinico, quale che sia il periodo più lungo
3) Risposta anticorpale positiva nota a FVIIa o a eventuali varianti rilevata durante lo screening e prima del Giorno 1
4) Ipersensibilità nota a pd-FVIIa, pd-FVII, wt rFVIIa o MarzAA o a uno qualsiasi degli eccipienti o prodotti correlati
5) Trattamento con anticoagulanti o terapia antipiastrinica entro una settimana dall'arruolamento o necessità anticipata nel corso dello studio
6) Chirurgia elettiva programmata entro 12 mesi dall'ingresso nello studio
7) Anamnesi di altri disturbi della coagulazione clinicamente rilevanti
8) Conta delle piastrine <50.000/µl in base alle valutazioni di laboratorio allo screening
9) Presenza o storia di aterosclerosi avanzata (ovvero anamnesi nota di coronaropatia [CAD], ictus ischemico, ecc.) o trombosi venosa profonda (DVT) o embolia polmonare (EP) nell'arco di 24 mesi di somministrazione o soggetto considerato ad alto rischio di evento tromboembolico venoso (VTE) in base al giudizio dello Sperimentatore
10) Concentrazione di cellule T CD4 <200 cellule/ mm3
11) Funzionalità epatica o renale compromessa
a) Livelli di alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) =5 × il limite superiore della norma (ULN)
b) Livello di bilirubina totale (TBIL) =2 mg/dl (>35 µmol/l) a meno che non sia presente un'anamnesi nota di sindrome di Gilbert (GS)
c) Livello di creatina sierica (Cr) >1,25 × ULN
12) Incapacità o problemi familiari, psicosociali o di salute che potrebbero impedire di portare a termine la partecipazione, di collaborare nelle procedure e di rispondere ai requisiti dello studio clinico come stabilito dal potenziale soggetto e dallo Sperimentatore
13) Peso =105 kg

E.5 End points

E.5.1

Primary end point(s)

Percentage of bleed treatments resulting in effective (Excellent or Good) hemostasis at 24 hours after the initial dose

Percentuale di episodi di sanguinamento trattati che hanno determinato un’emostasi efficace (eccellente o buona) 24 ore dopo la dose iniziale

E.5.1.1

Timepoint(s) of evaluation of this end point

24 hours after dosing

24 ore dopo la dose iniziale

E.5.2

Secondary end point(s)

• Time to cessation of bleeding after the initial dose
• Percentage of treated bleeding episodes resulting in effective hemostasis at the timepoints (Hours 1, 3 6, 9, 12, and 48) after the initial dose
• Number of doses and cumulative dose needed to achieve hemostasis for individual bleeds
• Percentage of bleeds with treatment success at 24 hours that maintain hemostatic response at 48 hours after the initial dose
• Use and amount of rescue therapy needed
• Population pharmacokinetics of subcutaneous MarzAA

• Tempo alla cessazione del sanguinamento dopo la dose iniziale
• Percentuale di episodi di sanguinamento trattati che hanno determinato un'emostasi efficace ai punti temporali di 1, 3, 6, 9, 12 e 48 ore dopo la dose iniziale
• Numero di dosi e dose cumulativa necessarie per ottenere l'emostasi per i sanguinamenti individuali
• Percentuale di sanguinamenti con successo di trattamento a 24 ore che mantengono la risposta emostatica a 48 ore dopo la dose iniziale
• Uso e quantità di terapia di salvataggio necessaria
• Farmacocinetica della popolazione trattata con MarzAA somministrato per via sottocutanea

E.5.2.1

Timepoint(s) of evaluation of this end point

Percentage of bleed treatment resulting in effective haemostasis at the timepoints (Hours 1, 3, 6, 9, 12, and 48) after the initial dose;
Percentage of bleeds with treatment success at 24 hours that maintain haemostatic efficacy at 48 hours after the initial dose

Percentuale di episodi di sanguinamento trattati che hanno determinato un'emostasi efficace ai punti temporali di 1, 3, 6, 9, 12 e 48 ore dopo la dose iniziale;
Percentuale di sanguinamenti con successo di trattamento a 24 ore che mantengono la risposta emostatica a 48 ore dopo la dose iniziale

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

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

standard terapeutico

standard of care

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

standard terapeutico

standard of care

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

Armenia

Georgia

India

Malaysia

Mexico

Russian Federation

South Africa

Taiwan

Turkey

Ukraine

United States

Bulgaria

Denmark

France

Hungary

Italy

Poland

Spain

United Kingdom

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

For subjects: A subject is considered to have completed the study if all assessments are completed including end of study visit.
For the study: when =244 bleeds have been treated with MarzAA (cumulative from both sequences) and =244 bleeds have been treated with SOC (cumulative from both sequences) and =80% of subjects have =3 eligible treated bleeds.

Per i soggetti: si considera che un soggetto abbia completato lo studio se tutte le valutazioni sono state completate, inclusa la visita di fine studio.
Per lo studio: quando =244 sanguinamenti sono stati trattati con MarzAA (cumulativo da entrambe le sequenze) e =244 sanguinamenti sono stati trattati con SOC (cumulativo da entrambe le sequenze) e =80% dei soggetti ha =3 sanguinamenti trattati ammissibili.

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

Yes

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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

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)

none

nessuno

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

2021-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-03

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

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