Clinical Trials Register

Summary
EudraCT Number:	2018-004946-41
Sponsor's Protocol Code Number:	SP-PP18
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:	2019-07-05
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

2018-004946-41

A.3

Full title of the trial

Personalized versus standard parenteral nutrition for preterm infants with a birth weight greater than 1250 grams: a phase IV randomized clinical trial

“Comparación entre nutrición parenteral individualizada y estándar en recién nacidos prematuros, con edad gestacional de menos de 37+0 semanas, y un peso al nacimiento superior a 1250 gramos: ensayo clínico aleatorizado.”

A.3.1

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

Personalized versus standard intravenous nutrition for small premature infants

Nutrición parenteral individualizada vs nutrición estándar en prematuros

A.4.1

Sponsor's protocol code number

SP-PP18

A.5.4

Other Identifiers

Name:

clinicaltrials.gov

Number:

NCT03693287

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	Dr. Virgilio P. Carnielli,
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Baxter Healthcare Ltd
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UNIVERSITA' POLITECNICA DELLE MARCHE
B.5.2	Functional name of contact point	SEGRETERIA SOD NEONATOLOGIA
B.5.3	Address:
B.5.3.1	Street Address	VIA ENRICO TOTI 4
B.5.3.2	Town/ city	ANCONA
B.5.3.3	Post code	60123
B.5.3.4	Country	Italy
B.5.4	Telephone number	0390715962045
B.5.6	E-mail	V.CARNIELLI@UNIVPM.IT

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	Yes
D.2.1.1.1	Trade name	NUMETA G13%E
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Healthcare Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLINOLEIC
D.3.9.3	Other descriptive name	FAT
D.3.9.4	EV Substance Code	SUB73474
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUCOSE
D.3.9.3	Other descriptive name	GLUCOSE
D.3.9.4	EV Substance Code	SUB13981MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Primene
D.3.9.3	Other descriptive name	AMINO ACIDS
D.3.9.4	EV Substance Code	SUB23205
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	59
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Yes
D.3.11.13.1	Other medicinal product type	A three chamber bag contains a sterile non-pyrogenic combination of glucose solution, amino acids solution and lipid emulsion.
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	Yes
D.2.1.1.1	Trade name	PRIMENE 10% solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	PRIMENE 10% solución para perfusión
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRIMENE
D.3.9.3	Other descriptive name	AMINO ACIDS
D.3.9.4	EV Substance Code	SUB23205
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	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	Yes
D.2.1.1.1	Trade name	ClinOleic
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	ClinOleic 20% emulsión para perfusión
D.3.4	Pharmaceutical form	Emulsion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLINOLEIC
D.3.9.3	Other descriptive name	FAT
D.3.9.4	EV Substance Code	SUB73474
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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: 4
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	Yes
D.2.1.1.1	Trade name	Glucosa B. Braun 50%
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Medical, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Glucosa B. Braun 50%
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUCOSE
D.3.9.3	Other descriptive name	GLUCOSE
D.3.9.4	EV Substance Code	SUB13981MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	10 to 70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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

Growth of preterm infants with a birth weight greater than 1250g on parenteral nutrition.

Crecimiento de recién nacidos prematuros con un peso al nacer superior a 1250 g y alimentados con nutrición parenteral.

E.1.1.1

Medical condition in easily understood language

Growth of small premature infants receiving parenteral nutrition

Crecimiento de recién nacidos con alimentación parenteral

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

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 compare the weight growth rate during the NP period in infants weighing more than 1250 grams and gestational age less than 37 + 0 W PMA prospectively randomized to receive a personalized or standard NP bag.

Comparar la tasa de crecimiento de peso durante el período de NP en bebés que pesan más de 1250 gramos y de edad gestacional de menos de 37 + 0 W PMA prospectivamente aleatorizados para recibir una bolsa NP personalizada o estándar .

E.2.2

Secondary objectives of the trial

1.Evaluation in all patients of metabolic tolerance (glucose, protein and lipids)

2. Evaluation of electrolytes and other minerals (sodium and potassium)
3. Evaluation of anthropometric parameters that include weight growth (daily), total length and cranial circumference (weekly).

4. Evaluation of body composition: evaluation of fat and lean body mass
5. Evaluation of mineralization
6. Evaluation of liver function
7. Days of NP
8. Contributions of NP and its variations with respect to the protocol of the Service
9. Days of mechanical ventilation
10. Duration of hospitalization
11. Incidence of intracranial hemorrhages IVH of 3rd and 4th grade and PVL.
12. Incidence of the pharmacological treatment and ligature of the PDA
13. Incidence of BPD.
14. Incidence of ROP
15. Incidence of sepsis
16. Cost of inpatient care.
17. Incidence of deaths in patients with PN.

1.Evaluación en todos los pacientes de la tolerancia metabólica (glucosa, proteína y lípidos)

2.Evaluación de electrolitos y otros minerales (sodio y potasio)
3. Evaluación de parámetros antropométricos que incluyen crecimiento de peso (diario), longitud total y circunferencia craneal (semanal).

4. Evaluación de la composición corporal: evaluación de la masa corporal grasa y magra
5. Evaluación de la mineralización
6. Evaluación de la función hepática
7. Días de NP
8. Contribuciones de NP y sus variaciones con respecto al protocolo del Servicio
9. Días de ventilación mecánica
10. Duración de la hospitalización
11. Incidencia de hemorragias intracraneales IVH de 3er y 4º grado y PVL.
12. Incidencia del tratamiento farmacológico y ligadura del PDA
13. Incidencia de BPD.
14. Incidencia de ROP
15. Incidencia de sepsis
16. Coste de la atención intrahospitalaria.
17. Incidencia de muertes en pacientes con NP.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Gestational age at birth < 37 weeks (or no more than 258 days);
- Birth weight > 1250 grams
- need of parenteral nutrition
- informed consent

peso superior a 1250 gramos y edad gestacional inferior a 37 + 0 W PMA de ambos sexos
 Consentimiento informado de los progenitores.
 Necesidad de NP (ver Apéndice 2)

E.4

Principal exclusion criteria

• high probability of death in the 7 days following the start of NP
• genetic, metabolic or endocrine disorders diagnosed before inclusion
• Withdrawal of consent for study by parents or legal representative.

• alta probabilidad de fallecimiento en los 7 días siguientes al inicio de la NP
• trastornos genéticos, metabólicos o endocrinos diagnosticados antes de la inclusión
• Retirada del consentimiento para el estudio por parte de los padres o el representante legal.

E.5 End points

E.5.1

Primary end point(s)

WEIGHT CHANGE: Daily weight change (g/kg/d) during parenteral
nutrition (NP)

Tasa de crecimiento de peso en el período NP (≥7 días).

E.5.1.1

Timepoint(s) of evaluation of this end point

From the start to the stop of PN(endpoint: PN day 28 if PN duration >28 days). At least 5 days of PN will be required to calculate weight gain.

Desde el inicio hasta el final de la NP (punto final: NP día 28 si la duración del NP es> 28 días). Se necesitarán al menos 5 días de NP para calcular el aumento de peso.

E.5.2

Secondary end point(s)

1. Body composition
2. Growth
3. Protein, glycemic or lipid tolerance
4. Bone mineralization

5. Evaluation of electrolytes and other minerals.
6. Evaluation of liver function
7. Duration of NP
8. Valuation of contributions regarding the service protocol
9. Days of Mechanical Ventilation.
10. Duration of hospitalization (readiness to discharge).
11. Hospitalization days.
12. Cost of inpatient treatment

1. Composición corporal
2. Crecimiento
3. Tolerancia protéica, glucémica o lipídica
4. Mineralización ósea

5. Evaluación de electrolitos y otros minerales.
6. Evaluación de la función hepática
7.Duración de la NP
8.Varación de los aportes respecto del protocolo del servicio
9.Días de Ventilación Mecánica.
10.Duración de la hospitalización (readiness to discharge).
11.Días de hospitalización.
12.Coste del tratamiento intrahospitalario

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Every 7 days from the beginning of the NP and until the suspension of the NP
2. Daily weight and length and per. cephalic weekly
3. Plasma and urinary area every 7 days from the beginning of the PN until the suspension and then at the end of each gestational week until high. Triglycerides every 7 days from the beginning of PN until suspension and then at the end of each gestational week. Glucose in daily blood during PN and then until discharge.
4. Bone scan every 7 days from onset of NP and until suspension.Ca and plasma phosphorus, alkaline phosphatase, Ca and urinary phosphorus every 7 days from onset of NP and until suspension.
5.7 days from the beginning of the PN until suspension and then until the end of each gestational week.
6. every 7 days from the start of NP and

1.Cada 7 días desde el comienzo de la NP y hasta la suspensión de la NP
2.Peso diario y longitud y per. cefálico semanalm.
3.Urea plasmática y urinaria cada 7 días desde el comienzo del NP hasta la suspensión y luego al final de cada semana gestacional hasta alta.Triglicéridos cada 7 días desde el comienzo del NP hasta suspensión y luego al final de cada semana gestacional.Glucosa en sangre diaria durante la NP y después hasta el alta.
4.Ecografía ósea cada 7 días desde inicio de la NP y hasta suspensión.Ca y fosforo plasmático, fosfatasa alcalina, Ca y fósforo urinario cada 7 días desde inicio de NP y hasta suspensión.
5.7 días desde comienzo del NP hasta suspensión y luego hasta la finalización cada semana gestacional.
6.cada 7 días desde el inicio del NP y hasta la suspensión

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

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

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

Ultima visita del último paciente

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:

150

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Yes

F.1.1.2.1

Number of subjects for this age range:

150

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)

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 will be studied. Parents or legal guardians will be required
for the partecipation in the study.

Se estudiarán los recién nacidos. Se requerirán padres o tutores legales para la participación en el estudio.

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

150

F.4.2.2

In the whole clinical trial

150

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

2019-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-06

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

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Clinical trials