Clinical Trials Register

Summary
EudraCT Number:	2018-003407-18
Sponsor's Protocol Code Number:	NN1436-4466
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:	2021-02-17
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

2018-003407-18

A.3

Full title of the trial

A trial comparing NNC0148-0287 C (insulin 287) versus insulin glargine U100, both in combination with metformin, with or without DPP4 inhibitors, in basal insulin treated subjects with type 2 diabetes mellitus

Studio clinico di confronto tra NNC0148-0287 C (insulina 287) e insulina glargine U100, entrambe in combinazione con metformina, con o senza inibitori DPP-4, in soggetti trattati con insulina basale affetti da diabete mellito di tipo 2

A.3.1

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

A research study in people with type 2 diabetes to compare two types of insulin: insulin 287 and insulin glargine

Studio clinico di confronto tra: insulina 287 e insulina glargine in persone con diabete di tipo 2

A.3.2

Name or abbreviated title of the trial where available

LAI287

A.4.1

Sponsor's protocol code number

NN1436-4466

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1219-5541

A.5.4

Other Identifiers

Name:

LAI287

Number:

NN1436-4466

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	Clinical Disclosure (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	No
D.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
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 287
D.3.2	Product code	[NNC0148-0287 C 4200 nmol/mL]
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.3.9.2	Current sponsor code	Insulina 287
D.3.9.4	EV Substance Code	SUB50453
D.3.10	Strength
D.3.10.1	Concentration unit	nmol/ml nanomole(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4200
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	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	LANTUS - 100 IU/ML SOLUZIONE INIETTABILE IN CARTUCCIA - USO SOTTOCUTANEO - CARTUCCIA VETRO PER OPTICLICK 3 ML" 5 CARTUCCE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS DEUTSCHLAND GMBH
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.3.1	Product name	LANTUS - 100 IU/ML
D.3.2	Product code	[NA]
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.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international 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 2

Diabete mellito di tpo 2

E.1.1.1

Medical condition in easily understood language

Diabetes Mellitus, Type 2

Diabete mellito di tpo 2

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	10045242
E.1.2	Term	Type II 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

To compare the effect on glycaemic control of treatment with once weekly insulin 287 using 2 different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4 inhibitors (DPP4i) in basal insulin analogue treated T2DM subjects.

Confrontare l’effetto sul controllo glicemico del trattamento con insulina 287 una volta a settimana usando due diversi approcci di passaggio in confronto all’insulina glargine U100 una volta al giorno entrambe in combinazione con metformina ± DPP4i in soggetti affetti da DMT2 trattati con analoghi dell’insulina basale

E.2.2

Secondary objectives of the trial

To compare the safety and tolerability of once weekly insulin 287 using 2 different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4i in basal insulin analogue treated T2DM subjects.

Confrontare la sicurezza e la tollerabilità dell’insulina 287 una volta a settimana usando 2 diversi approcci di passaggio in confronto all’insulina glargine U100 una volta al giorno entrambe in combinazione con metformina ± DPP4i in soggetti affetti da DMT2 trattati con analoghi dell’insulina basale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus = 180 days prior to the day of screening.
4. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
5. Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) = 90 days prior to the day of screening.
6. Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic
drug(s) or combination regime(s):
Any metformin formulations = 1500 mg or maximum tolerated or effective dose (as documented in subjects medical records)
Any metformin formulations = 1500 mg or maximum tolerated or effective dose with DPP4i = half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subjects medical records)
7. Body mass index (BMI) = 40.0 kg/m2

1. Modulo di consenso informato ottenuto prima di qualsiasi attività correlata alla sperimentazione. Per attività correlate alla sperimentazione si intende qualunque procedura svolta all’interno dello studio, incluse le attività necessarie a stabilire l’idoneità a partecipare.
2. Soggetti di sesso maschile o femminile, di età compresa tra 18-75 anni (estremi compresi) al momento della firma del modulo di consenso informato.
3. Soggetti che hanno ricevuto diagnosi di diabete mellito di tipo 2 =180 giorni prima del giorno dello screening.
4. Con valori di HbA1c compresi tra 7,0-10,0% (53,0-85,8 mmol/mol) (estremi compresi) secondo valutazione del laboratorio centrale.
5. Soggetti trattati con analoghi dell’insulina basale una volta o due volte al giorno (insulina degludec, insulina detemir, insulina glargine U100 o U300, con dose giornaliera totale di 10-50 U, estremi compresi) =90 giorni prima del giorno dello screening.
6. Dose/i giornaliera/e stabile/i di uno qualsiasi dei seguenti farmaci antidiabetici o regimi combinati nei 90 giorni precedenti il giorno dello screening:
qualsiasi formulazione di metformina =1.500 mg o dose massima tollerata o efficace (documentata nella cartella clinica del soggetto);
qualsiasi formulazione di metformina =1.500 mg o dose massima tollerata o efficace con DPP4i = metà della dose massima approvata secondo l’etichetta locale o dose massima tollerata o efficace (documentata nella cartella clinica del soggetto).
7. Indice di massa corporea (Body mass index, BMI) =40,0 kg/m2.

E.4

Principal exclusion criteria

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. For Czech Republic and Germany, please see country specific requirements in Appendix 10.
4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
5. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
6. Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
7. Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question 8.1
8. Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
10. Presently classified as being in New York Heart Association (NYHA) Class IV.
11. Planned coronary, carotid or peripheral artery revascularisation, between screening and randomisation.
12. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR <60 ml/min/1.73 m2 as defined by KDIGO 2012.13
13. Impaired liver function, defined as Alanine Aminotransferase (ALT) = 2.5 times or Bilirubin >1.5 times upper normal limit at screening
14. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic =180 mmHg or diastolic =110 mmHg) at screening.
15. 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.
16. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
17. Presence or history of malignant neoplasms within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed

1. Ipersensibilità nota o sospetta al/ai prodotto/i sperimentale/i o ai prodotti correlati.
2. Precedente partecipazione a questa sperimentazione. La partecipazione è definita come modulo di consenso informato firmato.
3. Soggetto di sesso femminile che sia in gravidanza, in allattamento o intenda iniziare una gravidanza o in età fertile e che non utilizzi misure contraccettive adeguate.
4. Partecipazione a qualsiasi sperimentazione clinica di un prodotto medicinale sperimentale approvato o non approvato nei 90 giorni precedenti allo screening.
5. Qualsiasi disturbo, eccetto le condizioni associate al diabete mellito di tipo 2, che, a giudizio dello sperimentatore, potrebbe mettere a rischio la sicurezza del soggetto o la conformità al protocollo.
6. Qualsiasi episodio di chetoacidosi diabetica negli ultimi 90 giorni precedenti il giorno dello screening e tra lo screening e la randomizzazione.
7. Inconsapevolezza di ipoglicemia nota, come indicato dallo sperimentatore in base alla domanda 8 del questionario di Clarke.1
8. Gravi episodi ipoglicemici ricorrenti nell’ultimo anno, secondo il giudizio dello sperimentatore.
9. Infarto del miocardio, ictus o ricovero in ospedale per angina instabile o attacco ischemico transitorio nei 180 giorni precedenti il giorno dello screening e tra lo screening e la randomizzazione.
10. Soggetti attualmente classificati nella Classe IV secondo la New York Heart Association (NYHA).
11. Prevista rivascolarizzazione arteriosa periferica, carotidea o coronarica tra lo screening e la randomizzazione.
12. Insufficienza renale misurata in termini di velocità di filtrazione glomerulare stimata (estimated Glomerular Filtration Rate, eGFR) con un valore eGFR <60 ml/min/1,73 m2 definito secondo la classificazione KDIGO 2012.*
13. Funzionalità epatica ridotta, definita come alanina aminotransferasi (ALT) =2,5 volte o bilirubina >1,5 volte il limite superiore di normalità allo screening.
14. Ipertensione inadeguatamente trattata allo screening, definita come ipertensione di Classe 3 o superiore (pressione arteriosa sistolica =180 mmHg e/o pressione arteriosa diastolica =110 mmHg) allo screening.
15. Trattamento con qualsiasi farmaco indicato per il diabete o l’obesità, diverso da quelli stabiliti nei criteri di inclusione, nel periodo dei 90 giorni precedenti al giorno dello screening.
16. Retinopatia o maculopatia diabetica non controllata o potenzialmente instabile, verificata mediante esame del fondo oculare eseguito negli ultimi 90 giorni precedenti lo screening o nell’intervallo di tempo compreso tra lo screening e la randomizzazione. La dilatazione farmacologica della pupilla è un requisito, a meno che non venga usata una fotocamera digitale specifica per un esame del fondo oculare senza dilatazione della pupilla.
17. Presenza o anamnesi di neoplasie maligne nei 5 anni precedenti al giorno dello screening. Sono consentiti il carcinoma cutaneo a cellule squamose e a cellule basali e qualsiasi carcinoma in situ

E.5 End points

E.5.1

Primary end point(s)

Time in target range 3.9–10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM)

Tempo trascorso nell’intervallo target di 3,9-10,0 mmol/l (70-180 mg/dl) misurato usando il CGM

E.5.1.1

Timepoint(s) of evaluation of this end point

Last 2 weeks of treatment (week 15 and 16)

Ultime 2 settimane di trattamento (Settimane 15 e 16)

E.5.2

Secondary end point(s)

1. Change in HbA1c
2. Change in fasting plasma glucose (FPG)
3. Change in body weight
4. Weekly insulin dose
5. Number of treatment emergent adverse events (TEAEs)
6. Number of severe hypoglycaemic episodes (level 3)
7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
8. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter)

1. Variazione nell’emoglobina glicata (HbA1c)
2. Variazione nella glicemia plasmatica a digiuno (Fasting Plasma Glucose, FPG)
3. Variazione nel peso corporeo
4. Dose settimanale di insulina
5. Numero degli eventi avversi emergenti dal trattamento (Treatment Emergent Adverse Events, TEAE)
6. Numero di episodi ipoglicemici gravi (livello 3)
7. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (<3.0 mmol/l [54 mg/dl], confermato mediante glucometro) o episodi ipoglicemici gravi (livello 3)
8. Numero di episodi di allerta ipoglicemica (livello 1) (da =3,0 a <3,9 mmol/l [da =54 a <70 mg/dl], confermato mediante glucometro)

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3.From baseline week 0 (V2) to week 16 (V18)
4. During the last 2 weeks of treatment (week 15 and 16)
5. From baseline week 0 (V2) to week 21 (V20)
6 -8 From baseline week 0 (V2) to week 16 (V18)

1-3 Dalla Settimana basale 0 (V2) alla Settimana 16 (V18)
4 Ultime due settimane di trattamento (settimana 15 e 16)
5 Dalla Settimana basale 0 (V2) alla Settimana 21 (V20)
6-8 Dalla Settimana basale 0 (V2) alla Settimana 16 (V18)

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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

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

Canada

United States

European Union

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 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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

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

2019-04-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-07

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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