Clinical Trials Register

Summary
EudraCT Number:	2017-003364-12
Sponsor's Protocol Code Number:	64091742PCR3001
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:	2021-06-17
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

2017-003364-12

A.3

Full title of the trial

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

Uno studio di fase III randomizzato, controllato con placebo, in doppio cieco su niraparib in associazione ad abiraterone acetato e prednisone contro abiraterone acetato e prednisone per il trattamento di soggetti con cancro prostatico metastatico

A.3.1

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

A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Patients with Metastatic Prostate Cancer

Uno studio di fase III su niraparib in associazione ad abiraterone acetato e prednisone contro abiraterone acetato e prednisone per il trattamento di pazienti con cancro prostatico metastatico

A.3.2

Name or abbreviated title of the trial where available

Magnitude

A.4.1

Sponsor's protocol code number

64091742PCR3001

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	JANSSEN CILAG INTERNATIONAL NV
B.1.3.4	Country	Belgium
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	Janssen Research & Development, LLC
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Janssen Cilag SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International N.V.
B.5.2	Functional name of contact point	Clinical Registry group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	000000000
B.5.5	Fax number	000000000
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	Niraparib 100 mg capsule
D.3.2	Product code	[JNJ-64091742]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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	NIRAPARIB
D.3.9.1	CAS number	1038915-60-4
D.3.9.2	Current sponsor code	JNJ-64091742
D.3.9.3	Other descriptive name	niraparib tosylate monohydrate
D.3.9.4	EV Substance Code	SUB177208
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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	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	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	niraparib/abiraterone 100/500mg (G010)
D.3.2	Product code	[CJNJ-67652000-G010]
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABIRATERONE ACETATE
D.3.9.1	CAS number	154229-18-2
D.3.9.2	Current sponsor code	ABIRATERONE ACETATE
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 200/1000 mg milligram(s), daily
D.3.9.4	EV Substance Code	SUB31647
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NIRAPARIB
D.3.9.1	CAS number	1038915-60-4
D.3.9.2	Current sponsor code	JNJ-64091742
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 200/1000 mg milligram(s), daily
D.3.9.4	EV Substance Code	SUB177208
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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	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	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: 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	niraparib/abiraterone 50/500mg (G009)
D.3.2	Product code	[CJNJ-67652000-G009]
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NIRAPARIB
D.3.9.1	CAS number	1038915-60-4
D.3.9.2	Current sponsor code	JNJ-64091742
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 100/1000 mg milligram(s), daily
D.3.9.4	EV Substance Code	SUB177208
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABIRATERONE ACETATE
D.3.9.1	CAS number	154229-18-2
D.3.9.2	Current sponsor code	ABIRATERONE ACETATE
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 100/1000 mg milligram(s), daily
D.3.9.4	EV Substance Code	SUB31647
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic Prostate Cancer

Carcinoma metastatico della prostata

E.1.1.1

Medical condition in easily understood language

Metastatic Prostate Cancer

Carcinoma metastatico della prostata

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 effectiveness of niraparib plus AA-P compared to AA-P plus placebo.

Valutare l’efficacia di niraparib + AA P rispetto ad AA-P + placebo

E.2.2

Secondary objectives of the trial

* To assess the clinical benefit of niraparib plus AA-P compared to AA-P plus placebo
* To characterize the safety profile of niraparib when given with AA-P compared to AA-P with placebo

* Valutare il beneficio clinico di niraparib + AA P rispetto ad AA-P + placebo
* Caratterizzare il profilo di sicurezza di niraparib quando viene somministrato con AA P rispetto ad AA-P con placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Criterion modified per Amendment 3
1.1 Criterion modified per Amendment 4
1.2 HRR gene alteration status (as identified by the sponsor's required assays or local testing for HRR gene alteration) as follows:
a. Cohort 1: positive for HRR gene alteration
b. Cohort 2: not positive for HRR gene alteration (ie, no HRR gene alteration)
c. Cohort 3
2. Metastatic disease documented by radiographic imaging
4. Able to continue GnRHa during the study if not surgically castrate
5. ECOG PS Grade of 0 or 1
6 Score of <=3 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours).
7. Adequate clinical laboratory values at Screening

1. Criterio modificato per l'emendamento3
1.1 Criterio modificato per l'emendamento 4
1.2 stato di alterazione del gene HRR (identificato secondo i test dello Sponsor o test locale per l'alterazione del gene HRR) :
a. Coorte 1: positiva per alterazioni del gene HRR
b. Coorte 2: non posistiva per alterazioni del gene HRR (ad es. nessuna alterazione del gene HRR)
2. Malattia metastatica documentata mediante imaging radiografico
4. Possibilità di proseguire l’assunzione di GnRHa durante lo studio per i soggetti non sottoposti a castrazione chirurgica
5. PS ECOG di grado 0 o 1
6. Punteggio <= 3 Alla Domanda n. 3 del questionario BPI-SF (Brief Pain Inventory-Short Form) (peggior dolore nelle ultime 24 ore)
7. Adeguati valori clinici di laboratorio allo screening

E.4

Principal exclusion criteria

1. Prior treatment with a PARP inhibitor
2. No prior systemic therapy for mCRPC except for GnRHa and limited AA-P
4. Symptomatic brain metastases
5. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
6. Other prior malignancy =2 years prior to randomization, or malignancy that currently requires active systemic therapy
7. Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g. adequate cardiac function), or clinically significant ventricular arrhythmias within 6 months prior to randomization or New York Heart Association (NYHA) Class II to IV heart disease
8. Presence of uncontrolled hypertension
9. Current evidence of any of the following:
a. Any medical condition that would make prednisone use contraindicated
b. Any chronic medical condition requiring a higher equivalent dose of corticosteroid than 10 mg prednisone (or equivalent) per day
11. History of adrenal dysfunction
13. Subjects who are receiving opioid analgesics at the time of screening
14. Active human immunodeficiency virus (HIV) infection

1. Precedente trattamento con un PARP-inibitore
2. Nessuna precedente terapia sistemica per mCRPC ad eccezione di GnRHa e limitato a AA-P
4. Metastasi cerebrali sintomatiche
5. Storia o diagnosi attuale della sindrome mielodisplastica (MDS) / leucemia mieloide acuta (LMA)
6. Altra neoplasia maligna precedente <= 2 anni prima della randomizzazione o neoplasia maligna che attualmente richiede la terapia sistemica attiva
7. Angina grave o instabile, infarto miocardico o ischemia che richiede un bypass aorto-coronarico o uno stent entro i 6 mesi precedenti, insufficienza cardiaca congestizia sintomatica, eventi tromboembolici arteriosi o venosi (ad es. adeguata funzione cardiaca) o aritmie ventricolari clinicamente significative entro 6 mesi precedenti alla randomizzazione o alla cardiopatia di classe New York Heart Association (NYHA) da II a IV
8. Presenza di ipertensione non controllata
9. Evidenza attuale di uno dei seguenti eventi:
a. Qualsiasi condizione medica che renderebbe l'uso di prednisone controindicato
b. Qualsiasi condizione medica cronica che richiede una dose di corticosteroide superiore a una dose di 10 mg di prednisone (o equivalente) una volrta al giorno
11. Storia di disfunzione surrenalica
13. Soggetti che assumono analgesici oppioidi al momento dello screening
14. Infezione attiva da virus dell'immunodeficienza umana (HIV)

E.5 End points

E.5.1

Primary end point(s)

Radiographic progression-free survival (rPFS)

Sopravvivenza libera da progressione radiografica (rPFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

While on study treatment, radiographic imaging will be performed at Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, and then every 12 weeks

Durante il trattamento di studio, l'imaging radiografico verrà eseguito al ciclo 3-giorno 1, ciclo 5 giorno 1, ciclo 7-giorno 1 e successivamente ogni 12 settimane.

E.5.2

Secondary end point(s)

* OS
* Time to symptomatic progression
* Time to initiation of cytotoxic chemotherapy
* Observed plasma concentrations of niraparib and abiraterone and estimated population PK and exposure parameters for niraparib
* Incidence and severity of AEs
* Clinical laboratory test results

* Sopravvivenza globale OS
* Tempo prima della progressione sintomatica
* Tempo prima dell’ inizio della chemioterapia citotossica
* Concentrazioni plasmatiche osservate di niraparib e abiraterone e farmacocinetica di popolazione stimata e parametri di esposizione per niraparib
* Incidenza e gravità degli eventi avversi
* Risultati dei test clinici di laboratorio

E.5.2.1

Timepoint(s) of evaluation of this end point

Assessments of the secondary endpoints are variable but carried out on a regular basis from C1D1 through the follow up as described in the endpoint requirements

Le valutazioni degli endpoint secondari sono variabili ma eseguite regolarmente dal C1D1 al follow up come descritto nei requisiti degli endpoint

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

Yes

E.6.7

Pharmacodynamic

Yes

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

Biomarker evaluations, PRO

Valutazioni Biomarker, PRO

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

105

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

China

Israel

Korea, Republic of

Malaysia

Mexico

Russian Federation

South Africa

Taiwan

Turkey

Ukraine

United States

Belgium

Bulgaria

France

Germany

Hungary

Italy

Netherlands

Poland

Portugal

Spain

Sweden

United Kingdom

Czechia

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:

260

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

840

F.2 Gender

F.2.1

Female

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

339

F.4.2.2

In the whole clinical trial

1100

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)

Protocol section 3.1: in the event of early completion or study termination by sponsor, the sponsor will continue to provide study treatments until unequivocal disease progression, unacceptable toxicity, or an alternate method is in place to avoid treatment interruption. In the event of positive study result at the final rPFS analysis for each cohort, sponsor may decide to allow the study to proceed into an Open-label Extension.

Protocollo Sezione 3.1: in caso di conclusione anticipata o interruzione dello studio da parte dello sponsor, lo sponsor continuerà a fornire trattamenti dello studio fino alla inequivocabile progressione della malattia, ad una tossicità inaccettabile o ad un metodo alternativo per evitare l'interruzione del trattamento. In caso di esito positivo dello studio all'analisi rPFS finale per ciascuna coorte, lo sponsor può decidere di consentire allo studio di procedere con un'estensione Open-label.

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

2019-02-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-22

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

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Clinical trials