ICH GCP - EU Clinical trials Registry - 2022-001795-34 (DE)

Page Nct des essais cliniques

Summary
EudraCT Number:	2022-001795-34
Sponsor's Protocol Code Number:	CL-N-HTX-Paed-II/10/20
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2022-09-15
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

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2022-001795-34

A.3

Full title of the trial

A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children

Eine prospektive, randomisierte, einfach blinde, multizentrische Phase II Studie zur Organperfusion mit Custodiol-N im Vergleich zu Custodiol bei Herztransplantation bei Kindern

A.4.1

Sponsor's protocol code number

CL-N-HTX-Paed-II/10/20

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/190/2021

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr. Franz Köhler Chemie GmbH
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	Dr. Franz Köhler Chemie GmbH
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	Deutsches Herzzentrum Berlin
B.5.2	Functional name of contact point	Deutsches Herzzentrum Berlin
B.5.3	Address:
B.5.3.1	Street Address	Augustenburger Platz 1
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13353 Berlin
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493045932087
B.5.5	Fax number	+493045932259
B.5.6	E-mail	knosalla@dhzb.de

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.2.1.1.1	Trade name	Custodiol-N
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. Franz Köhler Chemie GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Custodiol-N
D.3.4	Pharmaceutical form	Solution for cardioplegia/organ preservation
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracardiac use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium
D.3.9.3	Other descriptive name	Sodium
D.3.9.4	EV Substance Code	SUB15265MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium
D.3.9.3	Other descriptive name	Potassium
D.3.9.4	EV Substance Code	SUB14961MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Magnesium
D.3.9.3	Other descriptive name	Magnesium
D.3.9.4	EV Substance Code	SUB14407MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Calcium
D.3.9.3	Other descriptive name	Calcium
D.3.9.4	EV Substance Code	SUB13159MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.02
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Chloride ion
D.3.9.3	Other descriptive name	Chloride ion
D.3.9.4	EV Substance Code	SUB32047
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	29
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Histidine
D.3.9.1	CAS number	71-00-1
D.3.9.3	Other descriptive name	Histidine
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	124
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N-acetylhistidine
D.3.9.3	Other descriptive name	N-acetylhistidine
D.3.9.4	EV Substance Code	SUB216086
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	57
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glycine
D.3.9.3	Other descriptive name	Glycine
D.3.9.4	EV Substance Code	SUB12000MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sucrose
D.3.9.3	Other descriptive name	Sucrose
D.3.9.4	EV Substance Code	SUB12600MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	33
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	α -Ketoglutarate
D.3.9.3	Other descriptive name	OXOGLURIC ACID
D.3.9.4	EV Substance Code	SUB36364
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aspartic acid
D.3.9.1	CAS number	56-84-8
D.3.9.4	EV Substance Code	SUB11721MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Alanine
D.3.9.1	CAS number	56-41-7
D.3.9.3	Other descriptive name	Alanine
D.3.9.4	EV Substance Code	SUB05290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tryptophan
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	Tryptophan
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Arginine
D.3.9.3	Other descriptive name	L-Arginine
D.3.9.4	EV Substance Code	SUB05560MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Deferoxamine mesilate
D.3.9.1	CAS number	138-14-7
D.3.9.3	Other descriptive name	Deferoxamine
D.3.9.4	EV Substance Code	SUB01571MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.025
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LK614
D.3.9.3	Other descriptive name	N-hydroxy-3,4-dimethoxy-N-methyl-benzamide
D.3.9.4	EV Substance Code	SUB216084
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.0075
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)	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	Comparator
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.2.1.1.1	Trade name	Custodiol
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. Franz Köhler Chemie GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Custodiol
D.3.2	Product code	B05CX10
D.3.4	Pharmaceutical form	Solution for organ preservation
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracardiac use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium chloride
D.3.9.3	Other descriptive name	Sodium chloride
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium chloride
D.3.9.3	Other descriptive name	Potassium chloride
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Calcium chloride dihydrate
D.3.9.3	Other descriptive name	Calcium chloride dihydrate
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.015
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium chloride
D.3.9.3	Other descriptive name	Sodium chloride
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Histidine
D.3.9.1	CAS number	71-00-1
D.3.9.3	Other descriptive name	L-Histidine
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	198
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	D-Mannitol
D.3.9.3	Other descriptive name	D-MANNITOL
D.3.9.4	EV Substance Code	SUB20970
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	α -Ketoglutarate
D.3.9.3	Other descriptive name	OXOGLURIC ACID
D.3.9.4	EV Substance Code	SUB36364
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tryptophan
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	Tryptophan
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Preservation of hearts prior to heart transplantation in children

E.1.1.1

Medical condition in easily understood language

Preservation of hearts prior to heart transplantation in children

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10019314
E.1.2	Term	Heart transplant
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 objective of this investigation is to compare the safety of two organ preservation solutions,Custodiol and Custodiol-N, in paediatric
patients undergoing heart transplantation
Primary:
Safety assessment, i.e. continuous adverse event reporting up to 3 months

E.2.2

Secondary objectives of the trial

Main Secondary
- vital parameters up to day 7
- laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7
- Haemodynamics from termination of cardiopulmonary bypass until transfer to intensive care unit
- Death up to 3 months
- Graft survival up to 3 months
- Readmission to ICU up to 3 months
- Length of ICU stay up to 3 months
- Catecholamine requirement up to day 7
- Milrinone support up to day 7
- Need for pacemaker therapy up to day 7
- Need for mechanical circulatory support post-Tx
- Echocardiographic markers of function and rejection up to day 7
- Cardiac arrhythmias up to day 7

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patient criteria:
- Age from birth to less than18 years
- Recipients awaiting their first transplant
- Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
- written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
- Patient listed on the waiting list for heart transplantation
Donor criteria:
- deceased donors should fulfil the standard criteria for organ donation (SCD)

E.4

Principal exclusion criteria

Patient criteria:
- Patients who have participated within 30 days or are still participating in any other interventional studies
- history of severe organic disease other than concerning the heart
- history/demonstration of HIV antibodies or AIDS
- multiorgan transplantation
- machine-perfused organ
- the explantation team is affiliated to another clinic than transplantation team
-Failing Fontan patients
-Pregnancy and lactation

E.5 End points

E.5.1

Primary end point(s)

Safety assessment, i.e. continuous adverse event reporting up to 3 months

E.5.1.1

Timepoint(s) of evaluation of this end point

after transplantation and up to 3 months

E.5.2

Secondary end point(s)

Vital parameters (heart rate, blood pressure, body temperature) up to day 7
- Laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7
- CK-MB peak value from 4 to 168 hours after release of the aortic cross clamp (measurements 4, 8, 12, 16, 20, 24± 30 min; 32h, 40h, 48h, 56h, 64h,
72h ± 2 hours; visit 4-7 one time/interval)
- CK-MB AUC value visit 1-7
- Troponin T up to 168 hours after release of the aortic cross clamp (measurements 4, 8,12, 16, 20, 24 hours ± 30 min; 32h, 40h, 48h, 56h, 64h, 72h
± 2 hours; visit 4-7 one time/interval)
- Troponin AUC value visit 1-7
- Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation.
- Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to
intensive care unit (SBP, DBP), HR, PAP (if available), CVR (if available)
- Death up to 3 months
- Graft survival up to 3 months
- Readmission to ICU up to 3 months
- Length of ICU stays up to 3 months
- Catecholamine requirement (yes/no) up to day 7
- Antihypertensiva intake (yes/no) up to 3 months
- Milrinone support (yes/no) up to day 7
-Need for pacemaker therapy (yes/no) up to day 7
-Device therapy (each yes/no) up to 3 months (including LVAD, RVAD, ECMO, BIVAD or percutaneuos LVAD)
-Echocardiographic markers of function and rejection up to day 7 (Ejection fraction, enddiastolic and endsystolic ventricle volume)
-Cardiac arrhythmias up to day 7 (occurrence, severity, type)

E.5.2.1

Timepoint(s) of evaluation of this end point

- vital parameters and labor tests up to day 7 after transplantation
- Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation
- Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to intensive
care unit
- Death and graft survivial up to 3 months

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

E.6.7

Pharmacodynamic

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)

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

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 months

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:

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)

Yes

F.1.1.3.1

Number of subjects for this age range:

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)

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

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

newborns, infant and toddlers, children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

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

2023-01-24

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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