Clinical Trials Register

Summary
EudraCT Number:	2019-003431-33
Sponsor's Protocol Code Number:	19766
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-01-02
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

Portugal - INFARMED

A.2

EudraCT number

2019-003431-33

A.3

Full title of the trial

Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY 2433334 in patients following an acute non-cardioembolic ischemic stroke

Ensaio de Fase II para determinação de dose, multicêntrico, aleatorizado, controlado com placebo, com dupla ocultação e de grupos paralelos para avaliar a eficácia e a segurança de BAY 2433334 em doentes após um AVC isquémico agudo não cardioembólico

A.3.1

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

Study to gather information about proper dosing and safety of the oral FXIa inhibitor BAY 2433334 in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot has formed somewhere in the human body (but not in the heart) travelled to the brain.

Estudo para reunir informação sobre a dose apropriada e segurança do inibidor de FXIa BAY 2433334 em doentes que tiveram recentemente um AVC isquémico não-cardioembólico, que ocorre quando um coágulo de sangue se forma numa parte do corpo humano (mas não no coração) e se desloca para o cérebro.

A.3.2

Name or abbreviated title of the trial where available

PACIFIC-STROKE

A.4.1

Sponsor's protocol code number

19766

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	Bayer AG
B.1.3.4	Country	Germany
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	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	Müllerstrasse 178
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.6	E-mail	clinical-trials-contact@bayer.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	BAY 2433334
D.3.2	Product code	BAY 2433334
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	NA
D.3.9.1	CAS number	2064121-65-7
D.3.9.2	Current sponsor code	BAY 2433334 TABL 5 MG 201 COAT
D.3.9.3	Other descriptive name	BAY 2433334
D.3.9.4	EV Substance Code	SUB187352
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	5
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	BAY 2433334
D.3.2	Product code	BAY 2433334
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	NA
D.3.9.1	CAS number	2064121-65-7
D.3.9.2	Current sponsor code	BAY 2433334 TABL 15 MG 301 COAT
D.3.9.3	Other descriptive name	BAY 2433334
D.3.9.4	EV Substance Code	SUB187352
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	15
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	BAY 2433334
D.3.2	Product code	BAY 2433334
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	NA
D.3.9.1	CAS number	2064121-65-7
D.3.9.2	Current sponsor code	BAY 2433334 TABL 25 MG 401 COAT
D.3.9.3	Other descriptive name	BAY 2433334
D.3.9.4	EV Substance Code	SUB187352
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	25
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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

Non-cardioembolic ischemic stroke

Acidente vascular cerebral isquémico não-cardioembólico

E.1.1.1

Medical condition in easily understood language

Stroke which occurs when a blood clot has formed somewhere in the human body (but not in the heart) travelled to the brain

Acidente vascular cerebral que ocorre quando um coágulo de sangue se forma numa parte do corpo humano (mas não no coração) e se desloca para o cérebro.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10055221
E.1.2	Term	Ischemic stroke
E.1.2	System Organ Class	100000004852

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10067625
E.1.2	Term	Secondary prevention
E.1.2	System Organ Class	100000004865

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 the dose response of 3 different doses of BAY 2433334 compared to placebo in reducing the composite of symptomatic ischemic strokes and covert brain infarcts detected by MRI as well as other cerebro- and cardiovascular endpoints in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy.
• To evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy.

• Avaliar a resposta em função da dose de 3 doses diferentes de BAY 2433334 em comparação com placebo na redução do composto de AVC isquémicos sintomáticos e enfartes cerebrais ocultos detetados por ressonância magnética (RM), bem como outros parâmetros de avaliação final cerebrovasculares e cardiovasculares em participantes com um AVC isquémico agudo não cardioembólico e que são tratados com terapêutica antiplaquetária.

• Avaliar se a incidência de hemorragias com o BAY 2433334 é semelhante à observada com placebo em participantes com um AVC isquémico agudo não cardioembólico e que são tratados com terapêutica antiplaquetária.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant must be 45 years of age and older at the time of signing the informed consent
2. Non-cardioembolic ischemic stroke with
a. persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
b. acute brain infarction documented by computed tomography (CT) or MRI AND
c. with the intention to be treated with antiplatelet therapy during the study conduct
3. Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
4. Severity of index event nearest the time of randomization:
a. Part A: minor stroke (defined as NIHSS ≤ 7) can be enrolled
b. Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
5. Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
6. Ability to conduct an MRI either before randomization or within 72 hours after randomization

1. O participante deverá ter 45 anos de idade ou ser mais velho aquando da assinatura do consentimento informado.

2. Acidente vascular cerebral isquémico não-cardioembólico com
a. Sinais e sintomas persistentes do AVC que perdurem ≥ 24h ou
b. Enfarte cerebral agudo documentado por Tomografia Computorizada (TAC) ou por Ressonância Magnética (RM) e
c. com a intenção se ser tratado com terapêutica antiplaquetária durante a condução do ensaio

3. Imagiologia do cérebro (TAC ou RM) para descartar AVC hemorrágico ou outra patologia que possa explicar os sintomas (por exemplo tumor cerebral, abscesso, malformação vascular)

4. Severidade do evento índice mais próximo da hora da aleatorização:
a. Parte A: Pode ser incluído AVC ligeiro (definido como NIHSS ≤7)
b. Parte B: Podem ser incluídos participantes com AVC ligeiro a moderado e NIHSS ≤15). Participantes submetidos a trombólise ou terapia endovascular (trombectomia mecânica) podem ser incluídos mas nas primeiras 24h após a intervenção

5. Aleatorização até 48 horas após o início dos sintomas do evento índice (ou após a última vez, que se sabia, que os doentes estiveram sem sintomas em caso de AVC ao acordar)

6. Capacidade de realização de uma Ressonância Magnética antes da aleatorização ou até 72 horas após a aleatorização.

E.4

Principal exclusion criteria

1. Prior ischemic stroke within last 30 days of index event
2. History of atrial fibrillation or suspicion of cardioembolic source of stroke
3. Dysphagia with inability to safely swallow study medication at time of randomization
4. Contraindication to perform brain MRI
5. Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
6. Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization

1. Acidente vascular cerebral isquémico prévio nos últimos 30 dias antes do evento índice

2. História de fibrilhação auricular ou suspeita de origem cardioembólica do acidente vascular cerebral

3. Disfagia com incapacidade de deglutir com segurança os medicamentos do estudo no momento da aleatorização

4. Contra-indicação para realizar ressonância magnética cerebral

5. Apenas para Parte A: trombólise ou terapia endovascular (trombectomia mecânica) realizada para o evento índice

6. Hemorragia activa; distúrbio hemorrágico conhecido, história de hemorragia major (intracraniana, retroperitoneal, intra-ocular) ou clinicamente significativa, hemorragia gastrointestinal nos últimos 6 meses antes da aleatorização

E.5 End points

E.5.1

Primary end point(s)

Primary Efficacy Endpoint:
Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by MRI

Primary Safety Endpoint:
Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding

Parâmetro de avaliação final primário de eficácia
Número de participantes com AVC isquémico sintomático ou com enfartes cerebrais ocultos detetados por Ressonância Magnética

Parâmetro de avaliação final primário de segurança
Tempo desde a aleatorização até à primeira ocorrência de hemorragia major e hemorragia não major (CRNM) clinicamente relevante da Sociedade Internacional de Trombose e Hemostase (ISTH)

E.5.1.1

Timepoint(s) of evaluation of this end point

Primary Efficacy Endpoint: From baseline up to 6 months

Primary Safety Endpoint: From baseline up to 12 months

Parâmetro de avaliação final primário de eficácia: Desde a baseline até 6 meses.

Parâmetro de avaliação final primário de segurança: Desde a baseline até 12 meses

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints:
1.Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, CV death, myocardial infarction and systemic embolism
2.Number of participants with covert brain infarcts detected by MRI
3.Time from randomization to first occurrence of symptomatic ischemic stroke
4.Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction
5.Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke
6.Time from randomization to first occurrence of disabling stroke (mRS≥4)
7.Time from randomization to all-cause mortality

Secondary Safety Endpoints
1. Time from randomization to first occurrence of all bleeding
2. Time from randomization to first occurrence of ISTH major bleeding
3. Time from randomization to first occurrence of ISTH CRNM bleeding
4. Time from randomization to first occurrence of ISTH minor bleeding
5. Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic)

Parâmetro de avaliação final secundário de eficácia:
1. Número de participantes com composto de acidente vascular cerebral isquémico sintomático e enfartes cerebrais ocultos detetados por ressonância magnética, morte cardiovascular, enfarte do miocárdio e embolismo sistémico

2. Número de participantes com enfarte cerebral oculto detetado por ressonância magnética

3. Tempo desde a aleatorização até à primeira ocorrência de acidente vascular cerebral isquémico sintomático

4. Tempo desde a aleatorização até à primeira ocorrência de acidente vascular cerebral isquémico sintomático, morte cardiovascular, enfarte do miocárdio

5. Tempo da aleatorização até à primeira ocorrência de acidente vascular cerebral isquémico sintomático e acidente vascular cerebral hemorrágico

6. Tempo desde a aleatorização até à primeira ocorrência de acidente vascular cerebral incapacitante (mRS≥4)

7. Tempo desde a aleatorização até à mortalidade por todas as causas

Parâmetro de avaliação final secundário de segurança

1. Tempo desde a aleatorização até à primeira ocorrência de todas as hemorragias

2. Tempo desde a aleatorização até à primeira ocorrência de hemorragia major da ISTH

3. Tempo desde a aleatorização até à primeira ocorrência de hemorragia CRNM da ISTH

4. Tempo desde a aleatorização até à primeira ocorrência de hemorragia minor da ISTH

5. Tempo desde a aleatorização até à primeira ocorrência de hemorragia Intracerebral (não traumática)

E.5.2.1

Timepoint(s) of evaluation of this end point

From baseline up to 12 months

Desde a baseline até 12 meses

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

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers

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

Yes

E.8.1.7.1

Other trial design description

Dose-finding

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

166

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

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

Australia

Austria

Belgium

Bulgaria

Canada

China

Czechia

Denmark

Finland

Germany

Hungary

Italy

Japan

Netherlands

Poland

Portugal

Russian Federation

Slovakia

Spain

Sweden

Switzerland

United Kingdom

United States

France

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

Última visita do último participante (UVUP)

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:

900

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

900

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects with limited capacities to give consent due to the acute ischemic stroke symptoms and initial disabilities

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1400

F.4.2.2

In the whole clinical trial

1900

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

Nenhum

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

2020-03-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-03-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-02-17

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