Clinical Trials Register

Summary
EudraCT Number:	2021-002905-89
Sponsor's Protocol Code Number:	20186
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-10-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Portugal - INFARMED

A.2

EudraCT number

2021-002905-89

A.3

Full title of the trial

An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria

Um ensaio de extensão de segurança, de braço único, de 18 meses e em regime aberto com uma dose oral de finerenona ajustada à idade e ao peso corporal, em complemento a um iECA ou BRA, para o tratamento de crianças e jovens adultos com idade entre 1 e 18 anos com doença renal crónica e proteinúria

A.3.1

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

A study to learn more about how safe the study treatment finerenone is in long-term use when taken with an ACE inhibitor or angiotensin receptor blocker over 18 months of use in children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria

Um estudo para saber mais sobre o quão seguro é o tratamento a longo termo com finerenona quando tomado com um iECA ou BRA, durante 18 meses de uso em crianças e jovens adultos com idade entre 1 e 18 anos com doença renal crónica e proteinúria.

A.3.2

Name or abbreviated title of the trial where available

FIONA OLE

A.4.1

Sponsor's protocol code number

20186

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/298/2021

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 AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049303001139003
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	Finerenone
D.3.2	Product code	BAY 94-8862 10 mg
D.3.4	Pharmaceutical form	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	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
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	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	Finerenone
D.3.2	Product code	BAY 94-8862 20 mg
D.3.4	Pharmaceutical form	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	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
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	20
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	Finerenone
D.3.2	Product code	BAY 94-8862 granules 3.4%
D.3.4	Pharmaceutical form	Granules for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
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	103.6
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Treatment of children with chronic kidney disease and proteinuria

Tratamento de crianças com doença renal crónica e proteinúria.

E.1.1.1

Medical condition in easily understood language

Chronic kidney disease, which is long-term kidney disease, and proteinuria, a condition in which a person has extra protein in the urine

Doença renal crónica, que é a doença renal de longa duração, e proteinúria, uma condição na qual uma pessoa tem proteína em excesso na urina.

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10064848
E.1.2	Term	Chronic kidney disease
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10037032
E.1.2	Term	Proteinuria
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective is to demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.

Demonstrar que a finerenona em complemento a um inibidor da enzima conversora da angiotensina (iECA) ou um antagonista dos Bloqueador dos Recetores da Angiotensina (BRA) é segura quando administrada a longo prazo.

E.2.2

Secondary objectives of the trial

The secondary objective is to assess the long-term treatment effects on proteinuria and kidney function of finerenone in addition to standard of care.

Avaliar os efeitos do tratamento a longo prazo na proteinúria e na função renal da finerenona adicionada ao tratamento-padrão (TP).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
2. Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
3. Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
- CKD stages 1-3 (estimated glomerular filtration rate [eGFR] ≥30 mL/min/1.73m^2) for children ≥1 year to <19 years of age at FIONA EoT and at Visit 1
4. Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.
5. K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children <2 years of age at both FIONA EoT and Visit 1
6. Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.

1. Os participantes têm de ter uma idade ≥ 1 ano até 18 anos, no momento da assinatura do consentimento informado/assentimento.
2. Participação prévia no estudo de fase 3 da finerenona FIONA (19920) e sem descontinuação permanente do tratamento no momento da consulta de FT do estudo FIONA.
3. Os participantes têm de ter um diagnóstico clínico de DRC na consulta 1, que é definido como
DRC em estádios 1–3 (TFGe ≥ 30 mL/min/1,73 m2) para crianças com idade ≥ 1 ano até < 19 anos na consulta de FT do estudo FIONA e na consulta 1
4. Tratamento com um iECA ou ARA em doses otimizadas definidas como doses máximas toleráveis dentro da faixa de doses recomendada de acordo com as orientações sobre a gestão da PA, inalteradas durante pelo menos 30 dias antes da consulta 1
5. K+ ≤ 5,0 mmol/L para crianças com idade ≥ 2 anos tanto na consulta de FT do estudo FIONA como na consulta 1, e ≤ 5,3 mmol/L para crianças com idade
< 2 anos tanto na consulta de FT do estudo FIONA como na consulta 1
6. O participante pode receber alimentação enteral (alimento sólido, biberão ou copo, alimentação por sonda nasogástrica ou gástrica) com ou sem amamentação.

E.4

Principal exclusion criteria

1. Planned urological surgery expected to influence renal function
2. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
3. Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
4. Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants <18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) <90 mmHg in participants ≥18 years at Visit 1.
5. Known hypersensitivity to the study treatment (active substance or excipients)
6. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
7. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
8. Concomitant therapy with a mineralocorticoid receptor antagonist (MRA) (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
9. Concomitant therapy with both ACEI and ARBs together
10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers
11. Previous assignment to treatment during this study
12. Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
13. Experienced a drug-related serious adverse event (SAE) or an adverse event (AE) which led to permanent discontinuation of study intervention during the FIONA study
14. Pregnant or breastfeeding or intention to become pregnant during the study

1. Cirurgia urológica planeada que se preveja influenciar a função renal.
2. Doentes candidatos a transplante renal, ou seja, um transplante renal agendado dentro do prazo do estudo.
3. Hipertensão sistémica de estádio 2 definida de acordo com as orientações institucionais relativas à gestão da PA na consulta 1.
4. Hipotensão sistémica definida como hipotensão sintomática ou uma PA sistólica média abaixo do percentil 5 para a idade, sexo e altura, mas não inferior a 80 mmHg para participantes com idade < 18 anos e hipotensão sintomática ou uma PAS média < 90 mmHg em participantes com idade ≥ 18 anos na consulta 1.
5. Hipersensibilidade conhecida ao tratamento do estudo (substância ativa ou excipientes).
6. Insuficiência hepática grave definida por, por exemplo, Child-Pugh C ou pontuações análogas.
7. Participantes a utilizar rituximab, ciclofosfamida, abatacept ou glicocorticoides intravenosos.
8. Terapêutica concomitante com um ARM (eplerenona, espironolactona, esaxerenona, canrenona), qualquer inibidor da renina (alisquireno, enalquireno, remiquireno), qualquer inibidor do SGLT2 (SGLT2i), associação sacubitril/valsartan (ARNi) ou diurético poupador de potássio (amilorida, triantereno).
9. Terapêutica concomitante com iECA e ARA juntos.
10. Terapêutica concomitante com inibidores fortes da CYP3A4, indutores moderados ou fortes da CYP3A4.
11. Atribuição anterior ao tratamento durante este estudo.
12. Participação simultânea noutro estudo clínico interventivo (p. ex. estudos clínicos de fase 1 a 4).
13. Apresentou um AAG relacionado com o medicamento ou um AA que levou à descontinuação permanente da intervenção do estudo durante o estudo FIONA.
14. Gravidez ou amamentação ou intenção de engravidar durante o estudo.

E.5 End points

E.5.1

Primary end point(s)

1. Number of participants with treatment emergent adverse events (TEAEs)
2. Change in serum potassium levels from baseline to Day 540±7
3. Change in systolic blood pressure (SBP) from baseline to Day 540±7

1. Número de participantes com acontecimentos adversos emergentes de tratamento (AAET)
2. Alteração nos níveis séricos de potássio desde o início do ensaio até ao dia 540 ± 7
3. Alteração na pressão arterial sistólica (PAS) desde o início do ensaio até ao dia 540 ± 7

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 547 days

Até 547 dias

E.5.2

Secondary end point(s)

1. Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
2. Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7

1. Alteração na relação proteína/creatinina na urina (RPCU) e na relação albumina/creatinina na urina (RACU) desde o início do ensaio até ao dia 540 ± 7
2. Alteração na taxa de filtração glomerular estimada (TFGe) desde o início do ensaio até ao dia
540 ± 7.

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 547 days

Até 547 dias

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

E.8.1.1

Randomised

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

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

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

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

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

Canada

Israel

Korea, Republic of

United States

Switzerland

Turkey

Austria

Belgium

Czechia

Denmark

Finland

France

Germany

Greece

Hungary

Italy

Lithuania

Netherlands

Poland

Portugal

Spain

Sweden

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

The end of the study is defined as the date of the last visit of the last participant in the study globally.

O fim do ensaio é definido como a data da Última Visita do Último Participante no ensaio a nível global.

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

Number of subjects for this age range:

100

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

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

100

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)

After this open-label, single-arm safety extension study, continued access in a long-term study will be offered to participants until marketing authorization depending on country-specific requirements.

Após este ensaio de extensão de segurança, em regime aberto e de braço único, será oferecido aos participantes o acesso continuado num ensaio de longo termo até autorização de comercialização, dependendo dos requisitos específicos do país.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Conect4children (c4c)
G.4.3.4	Network Country	United Kingdom
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
G.4.3.4	Network Country	United States
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	ESCAPE
G.4.3.4	Network Country	Germany

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-02-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-13

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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Orphan Designation Number:
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Clinical trials