Clinical Trials Register

Summary
EudraCT Number:	2018-000232-10
Sponsor's Protocol Code Number:	NN8640-4245
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-07-30
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-000232-10

A.3

Full title of the trial

A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older

Studio clinico di determinazione del dosaggio che valuta efficacia e sicurezza di somapacitan, somministrato una volta a settimana, in confronto a Norditropin®, somministrato una volta al giorno, nei bambini a partire dai 2 anni di età, con bassa statura, nati piccoli per l’età gestazionale e con un catch-up growth non adeguato.

A.3.1

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

A research study in children born small and who stayed small. Treatment is somapacitan once a week compared to Norditropin® once a day

Studio clinico per la determinazione del dosaggio nei bambini a partire dai 2 anni di età, con bassa statura, nati piccoli per l’età gestazionale e con un recupero della crescita non adeguato. Confronto di somapacitan somministrato una volta a settimana rispetto a Norditropin®, somministrato una volta al giorno,

A.3.2

Name or abbreviated title of the trial where available

REAL5

NN8640-4245

A.4.1

Sponsor's protocol code number

NN8640-4245

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1207-9741

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.2.5	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	somapacitan 5 mg/1.5ml PDS290
D.3.2	Product code	[NN8640]
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	somapacitan
D.3.9.1	CAS number	1338578-34-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	somapacitan
D.3.9.4	EV Substance Code	SUB186254
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	3
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	No
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	somapacitan 10 mg/1.5ml PDS290
D.3.2	Product code	[NN8640]
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	somapacitan
D.3.9.1	CAS number	1333857-34-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	somapacitan
D.3.9.4	EV Substance Code	SUB186254
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	6
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	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.2.5	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	somapacitan 15 mg/1.5ml PDS290
D.3.2	Product code	[NN8640]
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	somapacitan
D.3.9.1	CAS number	1338578-34-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	somapacitan
D.3.9.4	EV Substance Code	SUB186254
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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: 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	No
D.2.1.1.1	Trade name	Norditropin FlexPro 10 mg/1.5 ml
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	Denmark
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	Norditropin FlexPro 10 mg/1.5 ml
D.3.2	Product code	[NN8640]
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	somatropin
D.3.9.1	CAS number	12629-01-5
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	somatropin
D.3.9.4	EV Substance Code	SUB10584MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	6
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

Short stature in children born small for gestational age with no catch-up growth by 2 years of age or older

Bambini con più di 2 anni di età con bassa statura e nati piccoli per l'età gestazionale e con un recupero di crescita non adeguato

E.1.1.1

Medical condition in easily understood language

Short stature in children born small for gestational age with no catch-up growth by 2 years of age or older

Bambini con più di 2 anni di età con bassa statura e nati piccoli per l'età gestazionale e con un recupero di crescita non adeguato

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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	10041093
E.1.2	Term	Small for gestational age
E.1.2	System Organ Class	100000004868

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of somapacitan versus Norditropin® on longitudinal growth in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older.

Confrontare l’efficacia di somapacitan rispetto a Norditropin® sulla crescita longitudinale nei bambini con bassa statura nati piccoli per l'età gestazionale e con un recupero della crescita non adeguato a partire dai due anni di età

E.2.2

Secondary objectives of the trial

To evaluate the effect and safety of somapacitan versus Norditropin® in children born small for gestational age with no catch-up growth by 2 years or older.

Confrontare l’efficacia e la sicurezza di somapacitan rispetto a Norditropin® sulla crescita longitudinale nei bambini con bassa statura nati piccoli per l'età gestazionale e con un recupero della crescita non adeguato a partire dai due anni di età

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Pre-pubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testes volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
- Born small for gestational age (birth length and/or weight less than -2 standard deviation scores (SDS)) (according to national standards)
- Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening
- Impaired height velocity defined as annualised height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment

-Bambini in età prepuberale:
a) Maschi:
o Età = 2 anni e 26 settimane e < 11,0 anni allo screening.
o Volume testicolo < 4 ml.
b) Femmine:
o Età = 2 anni e 26 settimane e < 10,0 anni allo screening.
o Fase 1 di Tanner per lo sviluppo del seno (nessun tessuto mammario ghiandolare palpabile).
-Nati piccoli per età gestazionale (peso e/o lunghezza alla nascita < -2 SDS) (secondo gli standard nazionali).
-Altezza insufficiente definita come almeno 2,5 di deviazione standard al di sotto dell’altezza media per età cronologica e sesso allo screening secondo gli standard Centers for Disease Control and Prevention
-Velocità di crescita ridotta, definita come velocità di crescita annualizzata inferiore al 50° percentile per età cronologica e sesso secondo gli standard Prader calcolati su un periodo di tempo minimo di 6 mesi e massimo di 18 mesi prima dello screening.
-Nessuna precedente esposizione alla terapia con ormone della crescita o trattamento con IGF-I.

E.4

Principal exclusion criteria

- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
- Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
- Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
- Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
- Diagnosis of attention deficit hyperactivity disorder
- Prior history or presence of malignancy including intracranial tumours

-Qualsiasi anomalia clinicamente significativa nota o sospetta che possa influire sulla crescita o sulla capacità di valutare la crescita con misurazioni dell’altezza in piedi:
-Bambini con carenze ormonali, compreso il deficit di ormone della crescita sospetto o confermato secondo standard nazionali.
-Malattie infiammatorie che hanno richiesto un trattamento sistemico con corticosteroidi per più di 2 settimane consecutive negli ultimi 3 mesi precedenti allo screening
-Bambini che hanno avuto bisogno di una terapia con glucocorticoidi per via inalatoria ad una dose superiore a 400 µg/die di budesonide o equivalenti per via inalatoria per più di 4 settimane consecutive nei 12 mesi precedenti allo screening
-Somministrazione concomitante di altri trattamenti che possono avere un effetto sulla crescita, quali, a titolo esemplificativo ma non esaustivo, metilfenidato per il trattamento del disturbo da deficit di attenzione e iperattività (Attention Deficit Hyperactivity Disorder, ADHD
-Diagnosi di disturbo da deficit di attenzione e iperattività.
-Anamnesi pregressa o presenza di tumori maligni noti inclusi i tumori intracranici.

E.5 End points

E.5.1

Primary end point(s)

Height velocity

Velocità di crescita

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline (week 0) to visit 5 (week 13)

Dalla visita basale alla visita 5 (settimana 13)

E.5.2

Secondary end point(s)

1. Change in bone age
2. Change in height SDS
3. Height velocity SDS
4. Change in fasting plasma glucose (FPG)
5. Change in homeostatic model assessment (HOMA)
6. Change in glycated haemoglobin (HbA1c)
7. Change in IGF-I SDS
8. Change in Insulin-like growth factor binding protein 3 (IGFBP-3) SDS

1. Cambiamento dell'età ossea
2. Modifica del punteggio di deviazione standard dell'altezza
3. Punteggio di deviazione standard della velocità in altezza
4. Variazione del glucosio plasmatico a digiuno
5. Modifica della valutazione del modello omeostatico
6. Modifica dell'emoglobina glicata (HbA1c)
7. Modifica del punteggio di deviazione standard del fattore di crescita I (IGF-I) insulino-simile
8. Modifica del punteggio di deviazione standard del fattore di crescita 3 (IGFBP-3) insulino-simile

E.5.2.1

Timepoint(s) of evaluation of this end point

1: From baseline (week 0) to visit 8 (week 52)
2, 3, 7 & 8: From baseline (week 0) to visit 5 (week 13)
4 - 6: From screening (visit 1) to visit 5 (week 13)

1: Dalla visita basale ( settimana 0) alla visita 8 (settimana 52),
2, 3, 7 & 8: Dalla visita basale ( settimana 0) alla visita 5 (settimana 13)
4 - 6: dalla visita di screening (visita 1) alla visita 5 (settimana 13)

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)

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

Algeria

Canada

Israel

Japan

Russian Federation

Thailand

Ukraine

United States

Switzerland

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

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

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

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

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.

Nessuna

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

2019-05-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-09

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

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