Clinical Trials Register

Summary
EudraCT Number:	2021-000602-17
Sponsor's Protocol Code Number:	CABL001A2001B
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-06-18
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

France - ANSM

A.2

EudraCT number

2021-000602-17

A.3

Full title of the trial

An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Etude d’extension (roll-over) multicentrique, en ouvert, évaluant la tolérance à long terme de l’asciminib chez des patients ayant terminé une étude évaluant l’asciminib promue par Novartis et qui pourraient tirer un bénéfice de la poursuite du traitement selon l’avis du médecin-investigateur

A.3.1

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

Study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Etude évaluant la tolérance à long terme de l’asciminib chez des patients ayant terminé une étude évaluant l’asciminib promue par Novartis et qui pourraient tirer un bénéfice de la poursuite du traitement selon l’avis du médecin-investigateur

A.4.1

Sponsor's protocol code number

CABL001A2001B

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	Novartis Pharma AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma S.A.S
B.5.2	Functional name of contact point	Information&Communication Médicales
B.5.3	Address:
B.5.3.1	Street Address	8/10 rue Henry Sainte Claire Deville, CS 40150
B.5.3.2	Town/ city	Rueil-Malmaison
B.5.3.3	Post code	92563
B.5.3.4	Country	France
B.5.4	Telephone number	+33 1 5547 6600
B.5.5	Fax number	+33 1 5547 6100
B.5.6	E-mail	icm.phfr@novartis.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/20/2261
D.3 Description of the IMP
D.3.1	Product name	Asciminib
D.3.2	Product code	ABL001
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	ASCIMINIB
D.3.9.2	Current sponsor code	ABL001
D.3.9.4	EV Substance Code	SUB188597
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	40
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/20/2261
D.3 Description of the IMP
D.3.1	Product name	Asciminib
D.3.2	Product code	ABL001
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	ASCIMINIB
D.3.9.2	Current sponsor code	ABL001
D.3.9.4	EV Substance Code	SUB188597
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	20
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: 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	Yes
D.2.1.1.1	Trade name	Glivec
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	Glivec
D.3.2	Product code	STI571
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	imatinib
D.3.9.1	CAS number	152459-95-5
D.3.9.2	Current sponsor code	STI571
D.3.9.3	Other descriptive name	IMATINIB
D.3.9.4	EV Substance Code	SUB25387
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	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: 4
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	Glivec
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	Glivec
D.3.2	Product code	STI571
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	imatinib
D.3.9.1	CAS number	152459-95-5
D.3.9.2	Current sponsor code	STI571
D.3.9.3	Other descriptive name	IMATINIB
D.3.9.4	EV Substance Code	SUB25387
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	400
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

CML-CP (at the end of parent study) who are currently participating in an asciminb Novartis sponsored study (parent study)

leucémie myéloïde chronique en phase chronique (LMC+PC) ayant participé à une étude clinique évaluant l’asciminib promue par Novartis (appelée « étude parente »)

E.1.1.1

Medical condition in easily understood language

Chronic Myelogenous Leukemia is a cancer of the blood characterized by a gene mutation (Philadelphia chromosome) which causes proliferation of white blood cells in the bone marrow.

La leucémie myéloïde chronique est un cancer du sang caractérisé par une mutation génétique (chromosome Philadelphia) qui entraine une prolifération des globules blancs dans la moelle osseuse

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10009012
E.1.2	Term	Chronic myelogenous leukemia
E.1.2	System Organ Class	100000004864

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

The primary objective of this study is to assess long term safety data (i.e SAEs and AEs)

L'objectif principal de cette étude est dévaluer les données de tolérance à long terme (effets indésirables et effets indésirables graves)

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to evaluate ongoing clinical benefit as assessed by the Investigator.

L'objectif secondaire de cette étude est dévaluer le bénéfice clinique continu selon l’évaluation du médecin-investigateur

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed informed consent must be obtained prior to participation in the study.
2. Participant with CML-CP (according to ELN guidelines 2013) is currently receiving treatment with asciminib (or asciminib in combination with imatinib, or imatinib alone or nilotinib alone for CABL001E2201 participants, or bosutinib for CABL001A2301 participants) within a Novartis-sponsored study, which has fulfilled the requirements for the primary objective and has completed treatment phase and, in the opinion of the Investigator, would benefit from continued treatment.
3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
4. Other protocol-defined inclusion criteria may apply

1. La signature du consentement éclairé doit être obtenue avant la participation à l’étude.
2. Patients atteints de LMC+PC (selon les recommandations 2013 du réseau européen des leucémies [ELN pour European Leukemia Net], Baccarani et al.) recevant actuellement un traitement par asciminib (ou asciminib en association avec l’imatinib, imatinib en monothérapie, nilotinib en monothérapie pour les patients participant à l’étude CABL001E2201, bosutinib pour les patients participant à l’étude CABL001A2301) au cours d’une étude promue par Novartis dont l’objectif principal a été atteint. Ces patients doivent avoir terminé la phase de traitement et pouvoir tirer un bénéfice de la poursuite du traitement, selon le médecin-investigateur.
3. Patients ayant montré une bonne observance des procédures de l’étude parente, selon le médecin-investigateur, et qui acceptent et sont capables de respecter le calendrier des visites, le schéma de traitement et toute autre procédure de l’étude.
4. D'autres critères d'inclusion définis par le protocole peuvent s'appliquer

E.4

Principal exclusion criteria

1. Participant has been discontinued from parent study treatment due to any reason.
2. Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have:
- not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities,
- not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities.
3. Participant’s ongoing treatment is currently approved and reimbursed at country level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 days after stopping asciminib, 14 days after stopping imatinib or nilotinib and one month after stopping bosutinib medication.
6. For participants in the USA and on asciminib treatment only: Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 3 days after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.
7. Applicable only for participants on bosutinib treatment at the end of the ABL001A2301 study that switch to asciminib treatment at enrollment:
-Asymptomatic (grade 2) pancreatitis if not resolved within 28 days.
-QTcF > 480 msec or inability to determine QTc interval
8. Other protocol-defined exclusion criteria may apply

1. Patients ayant arrêté le traitement à l’étude au cours de l’étude parente, quelle qu’en soit la raison.
2. Patients présentant des toxicités de grade 3 ou 4 possiblement liées au traitement de l’étude parente et :
- non résolues à un grade 2 ou moins dans les 42 jours et/ou nécessitant une interruption du traitement de plus de 42 jours, pour les toxicités hématologiques,
- non résolues à un grade 2 ou moins dans les 28 jours et/ou nécessitant une interruption du traitement de plus de 28 jours, pour les toxicités non hématologiques.
3. Le traitement que reçoit le patient est approuvé et remboursé au niveau national. Dans des cas exceptionnels où le traitement est remboursé au niveau national mais pas au niveau individuel, veuillez contacter l’équipe Novartis de l’étude.
4. Femmes enceintes ou qui allaitent.
5. Femmes en âge d’avoir des enfants, c’est-à-dire toutes les femmes physiologiquement aptes à être enceintes sauf si elles utilisent une méthode de contraception très efficace pendant toute la durée du traitement à l’étude et jusqu’à 3 jours après l’arrêt de l’asciminib, 14 jours après l’arrêt de l’imatinib ou du nilotinib, ou 1 mois après l’arrêt du bosutinib.
6. Critère non applicable en France.
7. Uniquement pour les patients sous traitement par bosutinib à la fin de l’étude CABL001A2301 et qui passent à l’asciminib au moment de l’inclusion dans l’étude :
- pancréatite asymptomatique (grade 2) si elle n’est pas résolue dans les 28 jours,
- intervalle QT corrigé par la formule de Fridericia (QTcF) > 480 ms ou impossibilité de déterminer l’intervalle QT corrigé.
8. D'autres critères d'exclusion définis par le protocole peuvent s'appliquer

E.5 End points

E.5.1

Primary end point(s)

The frequency and severity of AEs/SAEs

Fréquence et sévérité des effets indésirables et effets indésirables graves

E.5.1.1

Timepoint(s) of evaluation of this end point

End of Study of 5 years

Fin d'étude à 5 ans

E.5.2

Secondary end point(s)

Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits

Proportion de participants présentant un bénéfice clinique tel qu'évalué par le médecin-investigateur lors des visites programmées

E.5.2.1

Timepoint(s) of evaluation of this end point

End of Study of 5 years

Fin d'étude à 5 ans

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

Yes

E.8.1.7.1

Other trial design description

Roll-over study, Bosutinib patients have the option to switch to asciminib during the study

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

Brazil

Canada

China

Japan

Korea, Republic of

Lebanon

Mexico

Russian Federation

Saudi Arabia

Taiwan

Turkey

United States

Austria

Bulgaria

Denmark

France

Germany

Italy

Netherlands

Poland

Portugal

Romania

Spain

United Kingdom

Czechia

Argentina

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

Study is expected to remain open for 5 years or until one of the below scenario occurs for all participants, whichever comes first:
•ongoing treatment becomes available following product launch and/or subsequent reimbursement (where applicable)
•benefit-risk profile of ongoing treatment for participant is no longer positive
•participant meets treatment discontinuation criteria
•other access program becomes available or is identified (i.e. compassionate use, MAP, etc.) for ongoing treatment

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

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:

184

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

230

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)

Patients remain on the study as long as they benefit from the study treatment until the IMP gets available outside of the study. Patients that discontinue the study will be treated with local available standard of care.

Les patients restent dans l'étude tant qu'ils bénéficient du traitement à l'étude jusqu'à ce que le médicament soit disponible en dehors de l'étude. Les patients qui interrompent l'étude seront traités selon les normes de soins disponibles localement.

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

2021-08-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-27

P. End of Trial
P.	End of Trial Status	Trial now transitioned

Select Country:	Select Age Range:
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