Clinical Trials Register

Summary
EudraCT Number:	2019-003577-25
Sponsor's Protocol Code Number:	1907V921F
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:	2020-05-19
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

2019-003577-25

A.3

Full title of the trial

A Phase 1/2, Multicentre, Open-label Study to Evaluate the
Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric
Patients Who Are Receiving or Who Are About to Receive Treatment with Opioids

Studio multicentrico, in aperto di fase 1/2 per valutare la farmacocinetica, la sicurezza e la tollerabilità di naldemedina in pazienti pediatrici che sono o che stanno per essere trattati con oppioidi

A.3.1

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

Clinical research study to assess if naldemedine is safe and tolerable when admininstered to paediatric patients (patients under the age of 18) who
are receiving or about to receive treatment with a class of drugs called opioids

Studio clinico per valutare se naldemedina è sicura e tollerata quando somministrata in pazienti pediatrici (pazienti sotto i 18 anni) che sono trattati o che stanno per essere trattati con oppioidi

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

1907V921F

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/312/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Shionogi B.V.
B.1.3.4	Country	Netherlands
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	Shionogi & Co. Ltd
B.4.2	Country	Japan
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shionogi B.V.
B.5.2	Functional name of contact point	Regulatory Affairs Department
B.5.3	Address:
B.5.3.1	Street Address	5th floor, 33 Kingsway
B.5.3.2	Town/ city	London
B.5.3.3	Post code	WC2B 6UF
B.5.3.4	Country	United Kingdom
B.5.6	E-mail	shionogiclintrials-admin@shionogi.co.jp

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	Rizmoic
D.2.1.1.2	Name of the Marketing Authorisation holder	Shionogi B.V.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	naldemedine 0.2 mg film-coated tablets
D.3.2	Product code	N/A
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Naldemedine 0.2mg/g powder for oral suspension
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NALDEMEDINE
D.3.9.1	CAS number	916072-89-4
D.3.9.4	EV Substance Code	SUB177220
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Opioid induced constipation

Costripazione Indotta da Opioidi

E.1.1.1

Medical condition in easily understood language

Constipation resulting from treatment with a class of drugs called opioids

Costipazione dovuta al trattamento con una classe di farmaci chiamati oppioidi

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10071128
E.1.2	Term	Opioid induced constipation
E.1.2	System Organ Class	100000004856

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 evaluate the pharmacokinetics (PK) of naldemedine and nor-naldemedine after a single oral dose of naldemedine in paediatric patients who are receiving or who are about to receive opioids

Valutare la farmacocinetica, la sicurezza e la tollerabilita' di naldemedina in pazienti pediatrici che sono o che stanno per essere trattati con oppioidi

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of naldemedine after a single oral dose of
naldemedine.
To evaluate the PK of naldemedine after multiple, once daily oral doses of naldemedine through population PK in paediatric patients.
To evaluate the safety and tolerability of naldemedine after multiple, once daily oral doses of naldemedine in paediatric patients.
To evaluate the palatability of naldemedine powder for oral suspension and the ability to swallow naldemedine tablets.

Valutare la sicurezza e tollerabilità di naldemedina dopo la somministrazione di una singola dose orale di naldemedina
Valutare la PK di naldemedina dopo la somministrazione di dosi multiple orali una volta al giorno di naldemedina mediante la PK della popolazione in pazienti pediatrici.
Valutare la sicurezza e tollerabilità di naldemedina dopo la somministrazione di multiple dosi orali una volta al giorno di naldemedina in pazienti pediatrici
Valutare la palatabilità di naldemedina polvere per sospensione orale e la capacità di deglutizione delle compresse di naldemedina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients ≥ 6 months of age and < 18 years of age
2. Patients receiving treatment or expected to receive treatment with an opioid for pain
3. Have either newly diagnosed constipation, a history of constipation treated with laxatives, or expected to develop constipation after opioid treatment.
4. Patients able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and able to return for blood sampling at the 24-hour timepoint.
5. Patients able to comply with meal, tobacco, and concomitant medication restrictions
6. BMI within approximately the 3rd to 97th percentile for their age according to the World Health Organization (WHO) Child Growth Standard
7 a. Prepubescent male patients may participate. A postpubescent and sexually active male patient must agree to use appropriate contraception during the study and refrain from donating sperm during this period.
7 b. A premenarchal female patient is eligible to participate. If a female patient is menarchal she must be not pregnant, not breastfeeding, and agree to follow appropriate contraceptive guidance during the treatment period and for at least 30 days after the last dose of naldemedine.

1. Pazienti = 6 mesi di eta' e < 18 anni di eta'
2. Pazienti che sono o che stanno per essere trattati con oppioidi per il trattamento del dolore
3. Presentano una nuova diagnosi di stipsi, anamnesi di stipsi trattata con lassativi o si prevede che sviluppino stipsi dopo il trattamento con oppioidi.
4. Pazienti in grado di rimanere in clinica per proliovi si sangue per almeno 12 oredopo la prima somministrazione del farmaco e in grado di ritornare per il prelievo del sangue al timepoint a 24 ore.
5. Pazienti in grado di attenersi alle restrizioni di cibo, di tabacco e dei farmaci concomitanti
6. Indice di massa corporea approssimativamente tr ail terzo e il novantasettesimo percentile per la loro età in accordo agli standard di crescita per i bambini da parte dell’Organizzazione Mondiale della Sanità
7 a. I ragazzi prepubescenti possono partecipare. I ragazzi postpubescenti che sono sessualmente attivi devono acconsentire a metodi di contraccezione appropriati.
7 b. Le ragazze pre-menarca sono idonee alla partecipazione. Le ragazze post menarca non devono risultare incinta, non devono allattare, e devono devono seguire metodi di contraccezione appropriat durante il periodo di trattamento e almeno per 30 giorni dopo l’ultima dose di naldemedina

E.4

Principal exclusion criteria

1. Patients with a history of a GI neoplasm or an ongoing GI-related issue or any
recent (within last 1 year) or planned GI tract surgery
2. Patients with signs or symptoms of GI obstruction
3. Patients who have a nasogastric tube.
4. Patients who have reported no bowel movements for 7 consecutive days at the
time of obtaining informed consent or on the initial day of study intervention
administration (Study Day 1)
5. Patients with a history of more than 1 week of CTCAE Grade 3 neutropenia or
thrombocytopenia with clinical sequelae
6. Patients who need mechanical ventilation
7. Patients who have severe CTCAE Grade 3 or above hepatic or renal impairment
including end-stage renal disease requiring hemodialysis
8. Patients who have a history of hypersensitivity to naldemedine or any of its ingredients.
9. Patients who have previously received naldemedine.
10. Patients currently receiving their first cycle of chemotherapy
11. Patients currently participating in another study of an investigational drug product or have received another investigational drug product within 30 days or 5 half-lives, whichever is longer, before baseline
12. Positive pregnancy test for female patients of childbearing potential

1. Pazienti con anamnesi di neoplasia gastrointestinale (GI) o altro disturbo correlato al GI in atto o qualsiasi operazione chirurgica al tratto GI recente (entro 1 anno) o pianificata
2. Pazienti con segni o sintomi di occlusione GI
3. Pazienti con necessità di sonda nasogastrica.
4. Pazienti con assenza di evacuazioni per 7 giorni giorni consecutive al momento di ottenere il consenso informato o al giorno iniziale della somministrazione del farmaco in studio (giorno 1 dello studio)
5. Pazienti con anamnesi di neutropenia o trombocitopenia di grado 3 secondo CTCAE di piu’ di una settimana con sequele cliniche
6. Pazienti con necessità di ventilazione meccanica
7. Pazienti con compromissione epatica o renale severa di grado 3 e superiore secondo CTCAE incluso la malattia renale in stadio final richiedente emodialisi
8. Pazienti con storia clinica di ipersensivita’ a naldemedina o ad uno qualsiasi dei suoi ingredienti
9. Pazienti che hanno in precedenza ricevuto naldemedina.
10. Pazienti attualmente trattati con il primo ciclo di chemioterapia
11. Pazienti attualmente in trattamento con un altro farmaco in Sperimentazione o che hanno ricevuto un altro farmaco in sperimentazione nei 30 giorni precedenti o in 5 emite, qulunque sia piu’ lungo, dal basale
12. Test di gravidanza positive per le pazienti di sesso femminile potenzialmente fertili.

E.5 End points

E.5.1

Primary end point(s)

To evaluate the pharmacokinetics (PK) of naldemedine and nor-naldemedine after a single oral dose of naldemedine
-- PK parameters using standard non-compartmental method, e.g. Cmax, Tmax, AUC, AUC0-last, AUC0-inf, λz, t1/2,z of naldemedine and nor-naldemedine; and CL/F, MRT, and Vz/F for naldemedine only, and metabolic ratio of Cmax of nor-naldemedine to Cmax of naldemedine [MRM/U, Cmax] andmetabolic ratio of AUC of nor-naldemedine to AUC of naldemedine [MRM/U, AUC] for nor-naldemedine only

Valutare la farmacocinetica (PK) di naldemedina e nornaldemedina dopo la somministrazione di una singola dose orale di naldemedina
-Parametri di PK utilizzando il metodo non compartimentale standard (per es., concentrazione plasmatica massima [Cmax], tempo alla concentrazione plasmatica massima [Tmax], area sotto la curva concentrazione plasmatica tempo [AUC] dal tempo zero fino al tempo dell'ultima concentrazione quantificabile [AUC0-last], AUC estrapolata dal tempo zero all'infinito [AUC0-inf], costante della velocità di eliminazione terminale [λz] ed emivita di eliminazione terminale [t1/2,z] di naldemedina e nornaldemedina; nonché clearance totale apparente (CL/F), tempo medio di permanenza [MRT] e volume apparente di distribuzione nella fase terminale [Vz/F] solo per la naldemedina, e rapporto metabolico di Cmax della nornaldemedina rispetto alla Cmax della naldemedina [MRM/U, Cmax] e rapporto metabolico dell'AUC della nornaldemedina rispetto all'AUC della naldemedina [MRM/U, AUC] solo per la nornaldemedina)

E.5.1.1

Timepoint(s) of evaluation of this end point

7 days

7 giorni

E.5.2

Secondary end point(s)

To evaluate the safety and tolerability of naldemedine after a single oral dose of naldemedine
-- Using results of physical examinations, vital signs, 12-lead ECGs, clinical laboratory tests, treatment-emergent adverse events (TEAEs), treatment-related TEAEs,including gastrointestinal (GI) events, and
serious adverse events (SAEs) on Study Day 1
To evaluate the PK of naldemedine after multiple, once daily oral doses of naldemedine through population PK
-- using Results of population PK analysis
PK parameters using population PK analysis (e.g. Cmax, Tmax, AUC0-τ, accumulation ratio for Cmax calculated as ratio of Day 7 to Day 1 Cmax (RCmax), and accumulation ratio for AUC calculated as ratio of Day 7 to Day 1 AUC (RAUC) for naldemedine only
To evaluate the safety and tolerability of naldemedine after multiple, once daily oral doses of naldemedine
-- using results of physical examinations, vital signs, 12-lead ECGs, clinical laboratory tests, TEAEs, treatment-related TEAEs including GI events, SAEs, and pain assessment(s) on Study Days 2 through 7
To evaluate the palatability of naldemedine powder for oral suspension and the ability to swallow naldemedine tablets
--using results of self-reported visual analog scale (VAS) for palatability assessments of naldemedine powder for oral suspension for patients ≥ 6 years of age
-- Results of investigator’s or patient’s parent/legal guardian assessment of palatability of naldemedine powder for oral suspension for patients < 6 years of age, and, if possible, patients’ self-assessment using a VAS with facial hedonic scale
-- Results of self-reported ease of swallowing of naldemedine tablets

Valutare la sicurezza e tollerabilità di naldemedina dopo la somministrazione di una
singola dose orale di naldemedina
-Risultati degli esami obiettivi (compresa la valutazione dei sintomi da astinenza da oppioidi), parametri vitali (pressione arteriosa, frequenza del polso, frequenza respiratoria e temperatura corporea), elettrocardiogrammi a 12 derivazioni (ECG),
analisi cliniche di laboratorio, eventi avversi emergenti dal trattamento (TEAE), TEAE correlati al trattamento, compresi eventi gastrointestinali (GI) ed eventi avversi seri (SAE) nel Giorno 1 dello studio
Valutare la PK di naldemedina dopo la somministrazione di dosi multiple orali una volta al giorno di naldemedina mediante la PK della popolazione
-Risultati dell'analisi PK della popolazione
-Parametri di PK utilizzando l'analisi PK della popolazione (per es., Cmax, Tmax, AUC0-t, rapporto di accumulo per Cmax calcolato come il rapporto della Cmax del Giorno 7 rispetto al Giorno 1 (RCmax) e rapporto di accumulo per l'AUC calcolato come il rapporto dell'AUC del Giorno 7 rispetto al Giorno 1 (RAUC) solo per la naldemedina
Valutare la sicurezza e tollerabilità di naldemedina dopo la somministrazione di multiple dosi orali una volta al giorno di naldemedina
- Risultati degli esami obiettivi (compresa la valutazione dei sintomi da astinenza da oppioidi), parametri vitali (pressione arteriosa, frequenza del polso, frequenza respiratoria e temperatura), ECG a 12 derivazioni, analisi cliniche di laboratorio, TEAE, TEAE correlati al trattamento, compresi eventi GI, SAE e valutazione(i) del dolore nei Giorni 2- 7 dello studio
Valutare la palatabilità di naldemedina polvere per sospensione orale e la capacità di deglutizione delle compresse di naldemedina
--Risultati delle autovalutazioni della palatabilità di naldemedina polvere per sospensione orale in pazienti di età = 6 anni utilizzando la scala visuo-analogica (VAS)
--Risultati della valutazione della palatabilità di naldemedina polvere per sospensione orale in pazienti di età < 6 anni da parte dello sperimentatore o dei genitori/tutore legale del paziente e, se possibile, autovalutazione dei pazienti utilizzando una VAS con scala edonistico-facciale
--Risultati dell'autovalutazione della facilità di deglutizione delle compresse di naldemedina

E.5.2.1

Timepoint(s) of evaluation of this end point

- Study Day 1
-Day 1 and Day 7
-Study Days 2 through 7
-During the whole study

-Giorno 1 dello studio
-Giorno 1 e Giorno 7
- Dal Giorno 2 al giorno
-Durante tutto lo studio

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

E.6.6

Pharmacokinetic

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

use of the drug in pediatric population

Uso del farmaco nella popolazione pediatrica

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

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

France

Germany

Hungary

Italy

Netherlands

Serbia

Spain

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

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)

Once the patient has ended participation in the trial, he/she has the option to continue into an Extension Period of up to 24 weeks. Enrolment in the Extension Period will only be offered if the investigator considers it appropriate based on the clinical status of the patient.

Una volta che il paziente ha concluso la partecipazione allo studio, gli/le sara' offerta l'opzione di continuare in un periodo di estensione di 24 settimane. L'arruolamento al periodo di estensione di 24 settimane sara' offerrto solo se lo sperimentatore lo considerera' appropriato in base allo stato clinico del paziente

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

2020-10-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-15

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

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Clinical trials