Clinical Trials Register

Summary
EudraCT Number:	2021-002905-89
Sponsor's Protocol Code Number:	20186
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-07-27
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

Spain - AEMPS

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

Ensayo de extensión de seguridad de 18 meses, abierto y de un solo brazo, de un régimen de finerenona oral, ajustado por edad y peso corporal, añadido a un IECA o ARA II para el tratamiento de pacientes pediátricos y adultos jóvenes de 1 a 18 años con enfermedad renal crónica y proteinuria.

A.3.1

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

FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA – Open-Label safety Extension

Finerenona para el tratamiento de pacientes pediátricos con enfermedad renal crónica y proteinuria - Extensión de seguridad abierta.

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

Tratamiento de pacientes pediátricos con enfermedad renal crónica y proteinuria.

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

Enfermedad renal crónica, que es enfermedad renal a largo plazo, y proteinuria, una afección en la que una persona tiene proteína adicional en la orina.

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.

Demostrar que la finerenona, añadida a un inhibidor de la enzima convertidora de la angiotensina (IECA) o un antagonista de los receptores de la angiotensina (ARA II), es segura cuando se administra a largo plazo.

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.

Evaluar los efectos del tratamiento a largo plazo con finerenona añadida al tratamiento de referencia (TdR) sobre la proteinuria y la función renal.

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. Los participantes deben tener de ≥1 año a 18 años de edad en el momento de firmar el consentimiento informado/asentimiento.
2. Participación previa en el ensayo de fase III de finerenona FIONA (19920) y no haber interrumpido permanentemente el tratamiento en la visita de FdT en FIONA.
3. Los participantes deben tener un diagnóstico clínico de ERC en la visita 1, que se define como:
• ERC en estadios 1-3 (FGe ≥30 ml/min/1,73 m2) en participantes de ≥1 año a <19 años de edad al FdT en FIONA y en la visita 1.
4. Tratamiento con un IECA o ARA II en dosis optimizadas definidas como dosis máximas tolerables dentro del intervalo de dosis recomendado de acuerdo con las directrices sobre el control de la PA, sin cambios durante al menos 30 días antes de la visita 1.
5. K+ ≤5,0 mmol/l en pacientes pediátricos ≥2 años de edad tanto al FdT en FIONA como en la visita 1, y ≤5,3 mmol/l en pacientes pediátricos <2 años de edad tanto al FdT en FIONA como en la visita 1.
6. El participante puede recibir alimentación enteral (alimentos sólidos, alimentación con biberón o taza, alimentación a través de sondas nasogástricas o gástricas) con o sin lactancia materna.

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. Cirugía urológica planificada que previsiblemente influirá en la función renal.
2. Pacientes que son candidatos para trasplante renal, es decir, un trasplante de riñón programado dentro del intervalo de tiempo del ensayo.
3. Hipertensión sistémica en estadio 2 definida según las guías del centro sobre el control de la PA en la visita 1.
4. Hipotensión sistémica definida como hipotensión sintomática o PA sistólica media por debajo del percentil 5 para la edad, el sexo y la estatura, pero no inferior a 80 mm Hg para participantes <18 años e hipotensión sintomática o PAS media <90 mm Hg en participantes ≥18 años en la visita 1.
5. Hipersensibilidad conocida al tratamiento del ensayo (principio activo o excipientes).
6. Insuficiencia hepática grave definida, por ejemplo, como Child-Pugh C o puntuaciones análogas.
7. Participantes que reciben rituximab, ciclofosfamida, abatacept o glucocorticoides intravenosos.
8. Tratamiento concomitante con un antagonista de los receptores de mineralocorticoides (ARM) (eplerenona, espironolactona, esaxerenona, canrenona), cualquier inhibidor de la renina (aliskireno, enalkireno, remikireno), cualquier inhibidor del cotransportador sodio glucosa 2(SGLT2i), la combinación sacubitrilo/valsartán (INRA) o un diurético ahorrador de potasio (amilorida, triamtereno).
9. Tratamiento concomitante con IECA y ARA II juntos.
10. Tratamiento concomitante con inhibidores potentes de la isoenzima CYP3A4, inductores moderados o potentes de la isoenzima CYP3A4.
11. Asignación previa al tratamiento durante este ensayo.
12. Participación simultánea en otro ensayo clínico de intervención (p. ej., ensayos clínicos de fase I a IV).
13. Haber experimentado un AA relacionado con el medicamento o un AA que condujera a la interrupción permanente de la intervención del ensayo durante el ensayo FIONA.
14. Embarazada o amamantando o intención de quedarse embarazada durante el ensayo.

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 con acontecimientos adversos surgidos durante el tratamiento (AAST)
2. Variación en los niveles séricos de potasio desde la visita basal hasta el día 540 ± 7.
3.Variación en la presión arterial sistólica (PAS) desde la visita basal hasta el día 540 ± 7.

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 547 days

Hasta 547 días

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. Variación en el cociente proteína/creatinina en orina (CPCO) y en el cociente albúmina/creatinina en orina (CACO) desde la visita basal hasta el día 540 ± 7.
2. Variación en la TFGe desde la visita basal hasta el día 540 ± 7.

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 547 days

Hasta 547 días

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

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

Austria

Finland

France

Lithuania

Poland

Sweden

Netherlands

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Denmark

Hungary

Portugal

Turkey

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.

El fin del estudio se define como la fecha de la última visita del último participante en el estudio a nivel mundial.

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.

Después de este estudio abierto de extensión de seguridad de un solo brazo, se ofrecerá acceso continuo en un estudio a largo plazo a los participantes hasta la autorización de comercialización, dependiendo de los requisitos específicos del 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

2022-10-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-19

P. End of Trial
P.	End of Trial Status	Ongoing

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