Clinical Trials Register

Summary
EudraCT Number:	2017-000048-17
Sponsor's Protocol Code Number:	NN1250-4300
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-08-11
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

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.

Studio clinico di confronto di insulina degludec versus insulina detemir, in aggiunta all¿insulina aspart, in donne incinte con diabete 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

Studio clinico di confronto di insulina degludec versus insulina detemir, in aggiunta all¿insulina aspart, in donne incinte con diabete tipo 1.

A.3.2

Name or abbreviated title of the trial where available

EXPECT

A.4.1

Sponsor's protocol code number

NN1250-4300

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1191-3018

A.5.4

Other Identifiers

Name:

EXPECT

Number:

NN1250-4300

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. S.P.A.
B.1.3.4	Country	Italy
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 All¿
B.5.3.2	Town/ city	Bagsvaerd
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 U/ML-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-CARTUCCIA (VETRO)(PENFILL)- 3 ML - 5 PENFILL
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	Italy
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	Insulina degludec
D.3.2	Product code	NN1250
D.3.4	Pharmaceutical form	Suspension 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	INSULINA DEGLUDEC
D.3.9.1	CAS number	844439-96-9
D.3.9.2	Current sponsor code	NN1250
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 - 100 U/ML SOLUZIONE INIETTABILE 1 FIALA 10 ML USO SOTTOCUTANEO
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	Italy
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	Insulina aspart
D.3.2	Product code	N/A
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	INSULINA ASPART
D.3.9.1	CAS number	11694-23-6
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	INSULIN ASPART
D.3.9.4	EV Substance Code	SUB08915MIG
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 - 100 U/ML SOLUZIONE INIETTABILE USO SOTTOCUTANEO CARTUCCIA VETRO (PENFILL) 3 ML 1 CARTUCCIA
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	Italy
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	Insulina detemir
D.3.2	Product code	NN304
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	INSULINA DETEMIR
D.3.9.1	CAS number	169148-63-4
D.3.9.2	Current sponsor code	NN304
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Diabete Mellito tipo 1

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes

diabete 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	21.1
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.

Confrontare l'effetto in termini di controllo glicemico del trattamento con insulina degludec
IDeg OD rispetto all'insulina detemir OD/BID entrambe in aggiunta all' insulina aspart 2-4
volte al giorno assunta ai pasti in donne incinte con DMT1.

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.

Confrontare l'effetto del trattamento con insulina degludec IDeg OD rispetto all'insulina detemir OD/BID entrambe in aggiunta all' insulina aspart 2-4 volte al giorno assunta ai pasti in donne incinte con DMT1, in termini di:
sicurezza materna
esito della gravidanza

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

- Sesso femminile, maggiore/uguale 18 anni di età al momento della firma del modulo di consenso informato.
- Soggetti che hanno ricevuto diagnosi di diabete mellito tipo 1 maggiore /uguale 1 anno prima del giorno dello screening (visita 1).
- Trattamento con iniezioni giornaliere multiple di insulina per via sottocutanea o con infusione continua di insulina per via sottocutanea (Continuous Subcutaneous Insulin Infusion, CSII) o insulina inalatoria maggiore /uguale 90 giorni prima della visita di screening (visita 1).
- Intenzione di avviare una gravidanza nei 12 mesi successivi alla randomizzazione e volontà a sottoporsi a una consulenza pre-gravidanza, oppure il soggetto gravidanza con un feto singolo vivo intrauterino (settimana gestazionale da 8 a 13 [+6 giorni]) senza alcuna anomalia osservata alla randomizzazione, confermata da ecografia.
- HbA1c allo screening inferiore /uguale 8,0% (64 mmol/mol) analizzata dal laboratorio centrale.

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)

- Trattamento con qualsiasi farmaco indicato per il diabete o l’obesità, diverso da quelli stabiliti nei criteri di inclusione, nei 90 giorni precedenti la visita di screening.
- Soggetto in stato di gravidanza e con proteinuria valutata in base al rapporto proteine/creatinina nell’urina maggiore /uguale 300 mg/g in un campione di urina misurato allo screening.
- Il soggetto viene sottoposto a oppure avvia una gravidanza supportata da fecondazione in vitro o altro trattamento per l’infertilità.
- Trattamento con qualsiasi farmaco concomitante controindicato in gravidanza in base all’etichetta locale nei 28 giorni precedenti lo screening e tra lo screening e la randomizzazione per i soggetti non in stato di gravidanza e nei 28 giorni precedenti il concepimento e tra il concepimento e la randomizzazione perle donne in stato di gravidanza.
- Retinopatia proliferativa o maculopatia che necessita di trattamento acuto, verificata per mezzo di fotografia del fondo oculare o fondoscopia per dilatazione farmacologica eseguita entro i 90 giorni precedenti la visita randomizzazione (visita 2) per i soggetti non in stato di gravidanza o entro 28 giorni precedenti la visita randomizzazione (visita 2) per i soggetti in stato di gravidanza.
- Anamnesi di iperemesi gravidica grave (tale da richiedere un ricovero in ospedale).

E.5 End points

E.5.1

Primary end point(s)

Last planned HbA1c prior to delivery after gestational week (GW) 16.

Variazione dei valori di emoglobina glicata (HbA1c) alla visita programmata prima del parto rispetto alla settimana gestazionale (GW) 16.

E.5.1.1

Timepoint(s) of evaluation of this end point

After gestational week 16.

Dopo la settimana gestazionale (GW) 16.

E.5.2

Secondary end point(s)

Supportive maternal efficacy endpoints
1- HbA1c minore uguale 6.0% (42 mmol/mol) from last planned HbA1c prior to delivery (yes/no)
2. Last planned average post-prandial glucose (PPG) prior to delivery. Average of three main meals
3. Last planned fasting plasma glucose (FPG) prior to delivery after GW 16
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 major equal 140 mmHg systolic or major equal 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) and simultaneous proteinuria (defined as major = 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of major = 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 GWs) (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 minor = (31 mg/dL) during the first 24 hours after birth or minor = (45 mg/dL) between 24 hours and 48 hours after birth (yes/no)

Endpoint di supporto di efficacia materna
1. Valori di emoglobina glicata inferiori o uguali a 6,0% alla visita programmata prima del parto(si/no)
2. Ultimo valore medio previsto di glucosio post-prandiale (Post-Prandial Glucose, GPP) alla visita programmata prima del parto. Media di tre pasti principali.
3. Ultimo valore previsto di glicemia a digiuno (Fasting Plasma Glucose, FPG) alla visita programmata prima del parto.
Endpoint di supporto di sicurezza materna
4. Numero di episodi ipoglicemici
5. Sviluppo di retinopatia pericolosa per la vista, definita come retinopatia proliferativa o maculopatia (si/no)
6. Numero di eventi avversi durante il periodo di gravidanza
7. Preeclampsia definita come ipertensione di nuovo esordio (pressione sanguigna sistolica maggiore =140 mmHg o diastolica maggiore =90 mmHg, basata su almeno 2 misurazioni acquisite a distanza di almeno 4 ore l'una dall'altra) e proteinuria simultanea (definita come maggiore/uguale 300 mg di proteine in un campione di urine delle 24 ore, un rapporto proteine/creatinina maggiore =300 mg/g in un campione di urine o un valore di proteine 1+ alla striscia reattiva delle urine), oppure presenza di eclampsia, sindrome da HELLP [Hemolysis-Elevated Liver enzyme-Low Platelet (Emolisi-enzimi epatici elevati-piastrine basse)] o altro coinvolgimento serio di organi (s¿/no)
Endpoint di supporto di esito della gravidanza
8. Peso alla nascita (kg)
9. Parto pretermine (parto <37 GW completate) (s¿/no)
10. Presenza di anomalie maggiori (classificate secondo la EUROCAT)
11. Bambini nati vivi (si/no)
12. Numero di eventi avversi nel bambino
13. Episodi ipoglicemici neonatali definiti come glicemia minore /uguale (31 mg/dl) o minore/uguale (45 mg/dl) (si/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. Dopo la settimana gestazionale 16
4. Durante il periodo di gravidanza (dal primo giorno di gravidanza (data del concepimento) oppure dalla data di randomizzazione (a seconda dell'evento che si verifica per ultimo) fino alla data del parto.
6. Dal primo giorno di gravidanza [inteso come data del concepimento] o dalla randomizzazione [in base all'evento che si verifica per ultimo] al parto)
7. Dalla settimana gestazionale 20 al parto
8.-11. Alla nascita
12. Dal parto al follow-up finale
13. Durante le prime 24 ore dopo il parto o tra le 24 e le 48 ore dopo il parto

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

Information not present in EudraCT

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

Brazil

Canada

Israel

Russian Federation

Serbia

European Union

Argentina

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

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:

300

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

111

F.4.2.2

In the whole clinical trial

300

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

Nessuno

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

2017-10-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-18

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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