Clinical Trials Register

Summary
EudraCT Number:	2017-000048-17
Sponsor's Protocol Code Number:	NN1250-4300
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-07-04
Trial results	View results

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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-000048-17

A.3

Full title of the trial

A trial comparing the effect and safety of insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes.

Ensayo para comparar el efecto y la seguridad de insulina degludec frente a insulina detemir, ambas en combinación con insulina aspart, en el tratamiento de mujeres embarazadas con diabetes tipo 1

A.3.1

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

Research study comparing insulin degludec to insulin detemir, together with insulin aspart, in pregnant women with type 1 diabetes

Estudio de investigación para comparar insulina degludec con insulina detemir, ambas en combinación con insulina aspart, en mujeres embarazadas con diabetes tipo 1

A.4.1

Sponsor's protocol code number

NN1250-4300

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1191-3018

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	Novo Nordisk A/S
B.1.3.4	Country	Denmark
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	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Global Clinical Registry (GCR,1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@novonordisk.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	Yes
D.2.1.1.1	Trade name	Tresiba® 100 units/ml solution for injection in pre-filled pen
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN DEGLUDEC
D.3.9.1	CAS number	844439-96-9
D.3.9.4	EV Substance Code	SUB96394
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	Yes
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	Yes
D.2.1.1.1	Trade name	NovoRapid® FlexPen® 100 units/ml solution for injection in pre-filled pen
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN ASPART
D.3.9.1	CAS number	116094-23-6
D.3.9.3	Other descriptive name	INSULIN ASPART
D.3.9.4	EV Substance Code	SUB08195MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	Yes
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	Levemir® FlexPen® 100 units/ml solution for injection in pre-filled pen
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN DETEMIR
D.3.9.1	CAS number	169148-63-4
D.3.9.3	Other descriptive name	INSULIN DETEMIR
D.3.9.4	EV Substance Code	SUB02692MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	Yes
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

Diabetes Mellitus, Type 1

Diabetes Mellitus, Tipo 1

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes

Diabetes Tipo 1

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10045228
E.1.2	Term	Type I diabetes mellitus
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. To compare the effect on glycaemic control of insulin degludec once daily plus insulin aspart 2-4
times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times
daily with meals in a population of pregnant women with type 1 diabetes mellitus.

1. Comparar el efecto sobre el control de la glucemia de insulina degludec una vez al día más insulina aspart 2 4 veces al día con las comidas e insulina detemir una o dos veces al día más insulina aspart 2 4 veces al día con las comidas en una población de mujeres embarazadas con diabetes mellitus tipo 1.

E.2.2

Secondary objectives of the trial

1. To compare the effect on maternal safety of insulin degludec once daily plus insulin aspart 2-4
times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times
daily with meals in a population of pregnant women with type 1 diabetes mellitus.
2. To compare the effect on pregnancy outcome of insulin degludec once daily plus insulin aspart 2-4
times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times
daily with meals in a population of pregnant women with type 1 diabetes mellitus.

1. Comparar el efecto en la seguridad materna de insulina degludec una vez al día más insulina aspart 2 4 veces al día con las comidas e insulina detemir una o dos veces al día más insulina aspart 2 4 veces al día con las comidas en una población de mujeres embarazadas con diabetes mellitus tipo 1.
2. Comparar el efecto en el desenlace del embarazo de insulina degludec una vez al día más insulina aspart 2 4 veces al día con las comidas e insulina detemir una o dos veces al día más insulina aspart 2 4 veces al día con las comidas en una población de mujeres embarazadas con diabetes mellitus tipo 1.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Female, age at least 18 years at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening
- Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of screening
- The subject is planning to become pregnant within 12 months from randomisation and willing to undertake pre-pregnancy counselling or the subject is pregnant with an intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any observed anomalies at randomisation, confirmed by an ultrasound scan
- HbA1c at screening below or equal to 8.0% (64 mmol/mol) by central laboratory

- Mujeres de ≥ 18 años de edad en el momento de la firma del consentimiento informado.
- Diagnosticadas de diabetes mellitus tipo 1 ≥ 1 año antes del día de la selección.
- Tratadas con inyecciones subcutáneas diarias múltiples de insulina o con infusión subcutánea continua de insulina (ISCI) o con insulina inhalada ≥ 90 días antes del día de la selección.
- La paciente tiene previsto quedarse embarazada en los 12 meses siguientes a la aleatorización y está dispuesta a recibir asesoramiento previo al embarazo o está embarazada con un feto intrauterino vivo (semanas de gestación 8 a 13 (+6 días)) sin anomalías observadas en la aleatorización, confirmado mediante ecografía.
- HbA1c en la selección ≤ 8,0% (64 mmol/mol) en el laboratorio central.

E.4

Principal exclusion criteria

- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening
- Pregnant and having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300 mg/g in urine sample measured at screening
- Subject being treated or became pregnant with assistance of in vitro fertilisation or other medical infertility treatment
- Receipt of any concomitant medication contraindicated in pregnancy according to local label within 28 days before screening and between screening and randomisation for non-pregnant subjects and 28 days before conception and between conception and randomisation for pregnant subjects
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or pharmacologically dilated fundoscopy performed within the past 90 days prior to randomisation for non-pregnant subjects or within 28 days prior to randomisation for pregnant subjects
- History of severe hyperemesis gravidarum (requiring hospitalisation)

- Tratamiento con fármacos indicados para la diabetes o la obesidad distintos de los especificados en los criterios de inclusión en el periodo de 90 días antes del día de la selección.
- Embarazo y proteinuria evaluada mediante un cociente entre proteínas y creatinina en orina ≥ 300 mg/g en una muestra de orina medida en la selección.
- La paciente recibe tratamiento o se queda embarazada con ayuda de fecundación in vitro u otro tratamiento médico para la infertilidad.
- Recepción de cualquier medicamento concomitante contraindicado en el embarazo según la ficha técnica local en los 28 días previos a la selección y entre la selección y la aleatorización en las mujeres no embarazadas y 28 días antes de la concepción y entre la concepción y la aleatorización en las mujeres embarazadas.
- Retinopatía proliferativa o maculopatía con necesidad de tratamiento urgente Verificado mediante fotografía del fondo de ojo u oftalmoscopia con dilatación farmacológica realizada en los 90 días previos a la aleatorización en las pacientes no embarazadas o en los 28 días previos a la aleatorización en las mujeres embarazadas.
- Antecedentes de hiperémesis gravídica grave (con necesidad de hospitalización).

E.5 End points

E.5.1

Primary end point(s)

1. Last planned glycosylated haemoglobin (HbA1c) prior to delivery

1. Última hemoglobina glucosilada (HbA1c) prevista antes del parto

E.5.1.1

Timepoint(s) of evaluation of this end point

1. After gestational week 16

1. Después de la semana 16 de gestación

E.5.2

Secondary end point(s)

Supportive maternal efficacy endpoints
1. HbA1c ≤ 6.0% (42 mmol/mol) from last planned HbA1c prior to delivery (yes/no)
2. Last planned average post-prandial glucose prior to delivery. Average of three main meals.
3. Last planned fasting plasma glucose prior to delivery

Supportive maternal safety endpoints
4. Number of hypoglycaemic episodes
5. Development of sight-threatening retinopathy defined as proliferative retinopathy or
maculopathy (yes/no)
6. Number of adverse events during the pregnancy period
7. Pre-eclampsia defined as new-onset hypertension (blood pressure ≥ 140 mmHg systolic or
≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart)and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, HELLP syndrome, or other severe organ involvement (yes/no)

Supportive pregnancy outcome endpoints
8. Birth weight (kg)
9. Pre-term delivery (delivery < 37 completed gestational weeks) (yes/no)
10. Presence of major abnormalities (classified according to EUROCAT) (yes/no)
11. Live born infants (yes/no)
12. Number of adverse events in the infant
13. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or ≤ 2.5 mmol/L (45 mg/dL) between 24 hours and 48 hours after birth (yes/no)

Criterios de valoración de la eficacia maternos de apoyo
1. HbA1c ≤ 6,0% (42 mmol/mol) con respecto a la última HbA prevista1c antes del parto después de la semana 16 de gestación (sí/no).
2. Última glucosa posprandial media prevista antes del parto después de la semana 16 de gestación.
3. Promedio de tres comidas principales.
4. Última glucosa plasmática en ayunas prevista antes del parto después de la semana 16 de gestación.

Criterios de valoración de la seguridad maternos de apoyo
4. Número de episodios de hipoglucemia durante el periodo de embarazo (desde el primer día de gestación (fecha de la concepción) o aleatorización (lo que ocurra más tarde) hasta el parto).
5. Aparición de retinopatía que pone en peligro la vista, definida como retinopatía proliferativa o maculopatía con respecto al inicio del tratamiento, así como entre el comienzo del embarazo y la visita de final del tratamiento (sí/no).
6. Número de acontecimientos adversos durante el periodo de embarazo (desde el primer día de embarazo (fecha de la concepción) o aleatorización (lo que ocurra más tarde) hasta el parto).
7. Preeclampsia, definida como hipertensión de nueva aparición (presión arterial sistólica ≥ 140 mm Hg o diastólica ≥ 90 mm Hg, basada en al menos 2 determinaciones obtenidas con 4 horas de diferencia como mínimo) entre la semana 20 de gestación y el parto y proteinuria simultánea (definida como ≥ 300 mg de proteínas en una muestra de orina de 24 horas, un cociente entre proteínas y creatinina ≥ 300 mg/g en una muestra de orina o una proteína urinaria con tira reactiva de 1+) o presencia de eclampsia, síndrome HELLP u otra afectación orgánica grave (sí/no).

Criterios de valoración del desenlace del embarazo de apoyo
8. Peso al nacer (kg).
9. Parto prematuro (parto < 37 semanas de gestación transcurridas) (sí/no).
10. Presencia de anomalías importantes (clasificadas según EUROCAT) (sí/no).
11. Recién nacidos vivos (sí/no).
12. Número de acontecimientos adversos en el lactante desde el parto hasta el seguimiento final.
13. Episodios de hipoglucemia neonatal, definida como una glucosa plasmática ≤ 1,7 mmol/l (31 mg/dl) durante las primeras 24 horas después del nacimiento o ≤ 2,5 mmol/l (45 mg/dl) entre 24 y 48 horas después del nacimiento (sí/no).

E.5.2.1

Timepoint(s) of evaluation of this end point

1.-3. After gestational week 16
4. During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery)
5. From treatment baseline as well as from pregnancy baseline to the end of treatment visit
6. From first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery)
7. occurring from gestational week 20 to delivery
8. - 11. At birth
12. From delivery to final follow-up
13. During the first 24 hours after birth or between 24 hours and 48 hours after birth

1-3. Despues de la semana gestacional 16
4. Durante el embarazo ( desde el primer día de embarazo (decha de la concepción) o aleatorización (lo último que suceda) hasta el parto)
5. Desde el tratamiento de base así como desde el inicio del embarazo hasta la visita de fin de tratamiento.
6. Desde el primer día de embarazo (decha de la concepción) o aleatorización (lo último que suceda) hasta el parto.
7. Lo que ocurra desde la semana gestacional 20 hasta el parto.
8.-11. Al nacimiento
12. Desde el parto hasta el final del seguimiento.
13. Durante las primeras 24 horas desde el nacimiento o entre las 24-48 horas desde el nacimiemto

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

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)

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

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

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

Argentina

Australia

Brazil

Canada

European Union

Israel

Russian Federation

Serbia

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

LVLS

UVUP

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

214

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

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

214

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

2019-08-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-08-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials