Clinical Trials Register

Summary
EudraCT Number:	2020-003400-13
Sponsor's Protocol Code Number:	BST003
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-11-23
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

2020-003400-13

A.3

Full title of the trial

A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy with Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes

Etude de phase II multicentrique non randomisée évaluant le traitement par BST-236 chez les patients présentant un syndrome myélodysplasique de haut risque ou une leucémie aiguë myéloïde réfractaire ou en rechute, non éligibles à la chimiothérapie intensive

A.3.1

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

Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy with Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes

Étude évaluant le traitement par BST-236 chez les patients présentant un syndrome myélodysplasique de haut risque ou une leucémie aiguë myéloïde réfractaire ou en rechute, non éligibles à la chimiothérapie intensive

A.3.2

Name or abbreviated title of the trial where available

GFM- BST003

A.4.1

Sponsor's protocol code number

BST003

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	Groupe Francophone des Myélodysplasies (GFM)
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Biosight Ltd.
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Groupe Francophone des Myélodysplasies (GFM)
B.5.2	Functional name of contact point	Fatiha CHERMAT
B.5.3	Address:
B.5.3.1	Street Address	Hôpital Saint Louis Service Hématologie Séniors 1, avenue Claude Vellefaux
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75010
B.5.3.4	Country	France
B.5.4	Telephone number	+33171 20 70 59
B.5.5	Fax number	+33171 20 70 38
B.5.6	E-mail	fatiha.chermat-ext@aphp.fr

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	Information not present in EudraCT
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	EMA/OD/0000039550
D.3 Description of the IMP
D.3.1	Product name	BST-236
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Aspacytarabine
D.3.9.1	CAS number	2098942-57-3
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	1000
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

Patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy

Patients présentant un syndrome myélodysplasique de haut risque ou une leucémie aiguë myéloïde réfractaire ou en rechute, non éligibles à la chimiothérapie intensive

E.1.1.1

Medical condition in easily understood language

Higher-Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

syndrome myélodysplasique de haut risque ou une leucémie aiguë myéloïde

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10028536
E.1.2	Term	Myelodysplastic syndromes
E.1.2	System Organ Class	100000004851

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	10081514
E.1.2	Term	Acute myeloid leukemia refractory
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

To assess the efficacy and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy

Évaluer l'efficacité et l'innocuité du BST-236 chez les patients présentant un syndrome myélodysplasique de haut risque ou une leucémie aiguë myéloïde réfractaire ou en rechute, non éligibles à la chimiothérapie intensive

E.2.2

Secondary objectives of the trial

1. Time to CR, response duration, EFS, and overall survival
2. Safety and toxicity profile of BST-236 in this population
3. Duration of cytopenias , and time spent in hospitalization
4.Evaluate the prognostic impact of MRD for AML Patients

1. Délai d’obtention de la réponse complète, la durée de la réponse ; survie globale et la survie sans évènement ;
2. Tolérance et le profil de toxicité du BST-236 dans cette population ;
3. Durée des cytopénies et le temps d’hospitalisation
4. MRD post induction et post consolidation pour les patients LAM

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Documented diagnosis of MDS, according to World Health Organization (WHO) classification and assessed as higher risk MDS, prior to first line HMA treatment, according to the Revised International Prognostic Scoring System (IPSS-R) (IPSS-R overall score ≥ 4.5)
Or
2. Diagnosed AML according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia: ≥20% blasts in peripheral blood or bone marrow
3. Adult ≥18 years of age
3. Failure/relapse following prior first-line AML or MDS treatment, defined as:
For MDS:
i.Relapse after initial complete or partial response or stable disease with HI, according to International Working Group (IWG) 2006 criteria following treatment with; azacitidine, decitabine.
ii.Failure to achieve complete or partial response or stable disease with HI according to International Working Group (IWG) 2006 criteria after at least 4 cycles of azacitidine or decitabine all within the last 1 year.
iii.MDS progression while on azacitidine/decitabine treatment irrespective of the number of cycles the patient has received.
For AML:
i.Relapse after initial CR/CRi/CRh following treatment with; azacitidine, decitabine, LDAC, venetoclax+HMA, or venetoclax+LDAC
ii.Failure to achieve CR, CRh or CRi following at least 4 cycles of azacitidine or decitabine or 2 cycles of venetoclax+ HMA or Venetoclax+ LDAC all within the last 1 year.
iii.AML progression while on HMA, LDAC, or venetoclax+ HMA or Venetoclax+ LDAC irrespective of the number of cycles the patient has received.
5. The participant is not able to receive an allogeneic bone marrow transplantation (BMT) at the time of study enrolment (BMT may be an option once the patient completed the study).
6. Not eligible for intensive chemotherapy.
a.Age ≥75 years
Or
b.Age ≥18 years with at least one of the following comorbidities:
i.Significant heart or lung comorbidities, as reflected by at least one of the following:
•Left ventricular ejection fraction (LVEF) ≤50%
•Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected
•Forced expiratory volume in 1 second (FEV1) ≤65% of expected
•Chronic stable angina or congestive heart failure controlled with medication
ii.Other comorbidity that the Investigator judges as incompatible with intensive chemotherapy, which must be documented
7. Creatinine clearance (MDRD) equation or measured by 24 hours urine collection ≥45 mL/min
8. Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal (ULN), unless attributed to leukemia (in AML patients)
9. Total bilirubin ≤3 XULN unless due to Gilbert disease
10. performance status ≤ 2
11. Women of reproductive potential must have a negative serum pregnancy test within 48 hours of the first day of any BST-236 treatment course
12. Women of reproductive potential must use two forms of effective birth control methods
13. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 3 months following the last dose of study drug
14. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
15. Patient must be able to adhere to the study visit schedule and other protocol requirements.

1. SMD (selon WHO 2016) de haut risque selon le score R-IPSS (score ≥ 4.5) au diagnostic
Ou
2. LAM (selon WHO 2016) : ≥ 20% de blastes dans le sang périphérique ou dans la moelle au diagnostic
3. Âge ≥ 18 ans
4. Rechute/réfractaire à une première ligne de traitement, définie par :
a) Pour les patients SMD :
I.Rechute après une réponse initiale (complète ou partielle ou stable avec amélioration hématologique) à l’azacitidine ou la décitabine
II.Echec (absence de RC ou RP ou maladie stable avec amélioration hématologique) après au moins 4 cycles d’azacitidine ou de décitabine
III.Progression en cours de traitement par azacitidine ou décitabine, indépendamment du nombre de cycles reçus.
b) Pour les LAM :
I.Rechute après une réponse initiale (RC/RCi/RCh) à l’azacitidine, la décitabine, cytarabine faible dose (LDAC :20mg/m2/j), venetoclax+azacitine ou venetoclax+LDAC
II.Echec (absence de RC, RCh ou RCi) après 4 cycles d’azacitidine ou décitabine ou 2 cycles de venetoclax+azacitidine ou venetoclax + LDAC
III.Progression en cours de traitement par azacitidine, décitabine, LDAC, venetoclax+HMA, venetoclax+LDAC, indépendamment du nombre de cycles reçus.
5. Non éligible à une allogreffe de CSH au moment de l’inclusion (l’allogreffe de CSH reste une option au cours du traitement)
6. Non éligible à une chimiothérapie intensive :
a) Âge ≥ 75 ans
Ou
b) Âge ≥ 18 ans avec au moins une des comorbidités:
I.Comorbidités cardiaques ou pulmonaires :
•Fraction d'éjection ventriculaire gauche (FEVG) ≤ 50%
•EFR : DLCO ≤ 65% et FEV1 ≤ 65%
•Maladie cardio-vasculaire contrôlée (angine de poitrine ou insuffisance cardiaque)
•Autre comorbidité jugé par l’investigateur comme incompatible à la chimiothérapie intensive (documentée)
7. Performance status  2 (ECOG)
8. Les femmes en âge de procréer :
a) Accepter une contraception efficace sans interruption durant toute la durée de l’étude et jusqu’à 3 mois après la fin du traitement.
b) Accepter une surveillance par un test de grossesse 48 heures avant chaque cycle de traitement.
9. Les hommes doivent accepter d’utiliser des préservatifs chaque fois qu’ils ont des rapports sexuels pendant toute la durée du traitement et jusqu’à 3 mois après l’arrêt du traitement.
10. Le patient doit être capable de se rendre aux visites médicales nécessaires à cette étude et d’adhérer au suivi selon le protocole.
11. Les patients doivent comprendre et signer le consentement éclairé
12. Résultats biologiques dans les limites décrites ci-dessous:
- Clairance de la créatinine ≥ 45 mL/min calculée selon les formules MDRD ou mesurée à partir de la diurèse des 24 heures
- Bilirubine sérique totale: ≤ 3x ULN (sauf maladie de Gilbert)
- AST (SGOT) et ALT (SGPT) ≤ 2.5 x ULN (sauf si attribuée à la LAM

E.4

Principal exclusion criteria

1. MDS or AML evolving from a pre-existing myeloproliferative neoplasm (MPN)
2. MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
3. Acute promyelocytic leukemia
4. Previous treatment for AML or MDS with drugs other than HMA or combinations of venetoclax with either HMA or LDAC
5. Previous allogeneic HSCT or solid organ transplantation
6.Participation in a previous clinical trial involving use of an investigational drug within 90 days or at least 5 half-lives of tested drug (whichever is shorter) of study day 1
7. Peripheral White Blood Cell (WBC) count >30,000 /L in the 48 hours prior to first BST-236 dose administration. Hydroxyurea administration or leukapheresis is permitted to meet this criterion
8. Administration of HMA, LDAC or venetoclax within 14 days prior to Study Day 1
9. Previous treatment with cytarabine at a dose higher than 20 mg/m2/ d
10. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
11. Any medical or surgical condition, presence of laboratory abnormalities or psychiatric illness that may preclude safe and complete study participation based on the Investigator’s judgment
12. Diagnosis of malignant disease (other than AML) within the previous 12 months (excluding basal cell carcinoma of the skin without complications, “in-situ” carcinoma, or other local malignancy excised or irradiated with a high probability of cure and not treated with systemic or topical chemotherapy)
13. Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to first BST-236 dose administration
14. History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine
15. Life expectancy shorter than 3 months attributed to any known medical condition other than AML/MDS
16. Known infection with Hepatitis B Virus (HBV) Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
17. In 12 leads ECG, QTc>480msec or history of QT prolongation or Torsades de pointes

1. SMD ou LAM secondaire à une syndrome myéloprolifératif (SMP)
2. SMD/SMP dont les LMMC, LMC atypique, leucemie myélomonocytaire juvénile ou SMD/SMP inclassable
3. Leucémie aiguë promyélocytaire
4. LAM ou SMD antérieurement traités par d’autres drogues qu’un hypométhylant, LDAC, ou combinaison de venetoclax et hypométhylant ou LDAC
5. Antécédent d’allogreffe de CSH ou de transplantation d’organe
6. Utilisation d’agents en cours d’investigation dans les 90 jours (ou cinq demi-vies) ou de tout agent anticancéreux dans les 2 semaines précédant la première administration de BST-236, à l’exception de l’hydroxyurée
7. Taux de leucocytes >30 G/l dans les 48 heures avant la première administration de BST-236. L’utilisation d’hydroxyurée ou d’une leukaphérèse est autorisée
8. Infection ou toute affection sévère non contrôlée
9. Toute affection médicale ou psychiatrique faisant courir au patient
10. Cancer actif ou antécédents de pathologie maligne autre que la LAM au cours de l’année précédant l’entrée dans l’essai (exception du carcinome basocellulaire ou épidermoïde ou d’un carcinome in-situ du col de l’utérus ou du sein)
11. Antécédent de chirurgie (en dehors d’une pose de voie veineuse centrale ou autres micro-chirurgies dans les 14 jours précédents la première administration de BST)
12. Hypersensibilité connue aux composants du BST-236 et/ou à la cytarabine.
13. Espérance de vie de moins de 3 mois attribué à une autre condition médicale que la LAM/SMD
14. Infection active connue par le VIH, VHB, VHC
15. Allongement du QTc>480 ms ou antécédent de QT prolongé ou de torsades de pointes

E.5 End points

E.5.1

Primary end point(s)

For MDS patients:
Overall response rate (ORR), defined as the proportion of patients who achieve a CR or PR per proposal for modification of the International Working Group (IWG) criteria for MDS, 2006
For AML patients:
CR Rate, defined as the proportion of patients who achieve a CR per the IWG 2006 Criteria

Pour les patients SMD :
La réponse hématologique globale après 1 induction (RC, RP, maladie stable avec amélioration hématologique selon les critères IWG 2006)
Pour les patients LAM :
Le taux de rémission complète après 1 ou 2 inductions.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of BST-236 induction whether patients received one or two induction cycle(s)

a la fin de l'induction du BST-236, si les patients ont reçu un ou deux cycles d'induction

E.5.2

Secondary end point(s)

For MDS patients:
1. Overall improvement rate (OIR), defined as the proportion of patients reaching a CR, Marrow CR, PR, or hematologic improvement (HI) per proposal for modification of the IWG criteria for MDS, 2006
2. Duration of Response (DOR
3. Progression Free Survival (PFS), for patients with at least a PR
4. Overall Survival (OS)
5. Rate of bone marrow blast response
6.Time to AML transformation
7. CR Rate,
8. Improvement in cytopenia
9. Rate of HI

For AML patients:
1. Overall response rate (ORR) including; CR (MRD+ , MRD-), CRh, and CRi according to the Diagnosis and Management of AML in Adults: 2017 ELN Recommendations from an International Expert Panel Revised
2. Duration of Response (DOR)
3. Progression Free Survival (PFS)
4. Overall Survival (OS)
5. Rate of bone marrow blast response
6. Rate of CR without Minimal Residual Disease (CR-MRD)
7. Time to neutrophil recovery in patients with CR or PR
8. Time to platelet recovery in patients with CR or PR
9. Rate of patients who become platelet transfusion-independent
10. Rate of patients who become red blood cell (RBC) transfusion-independent,

Pour les patients SMD :
1. Le taux de réponse globale : RC, RCi, RP et amélioration hématologique
2. La durée de la réponse et le temps de réponse.
3. La survie globale et la survie sans évènement.
4. Le taux et le temps de progression en LAM
5. La durée des cytopénies
6. La réponse cytogénétique

Pour les patients LAM :
1. Le taux de réponse globale : RC (MRD+, MRD-), RCh, RCi
2. La durée de la réponse et le temps de réponse
3. La survie globale et la survie sans évènement
4. Le taux de RC MRD- (évaluée en CMF)
5. Le profil de toxicité incluant la durée des cytopénies et l’indépendance transfusionnelle

E.5.2.1

Timepoint(s) of evaluation of this end point

After LPLV (EOS)

Après la dernière visite du dernier patient

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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)

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

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.8.3

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.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)

Treatment with BST-236 stops at thelatest consolidation. No treatment with BST-236 is possible after this treatment period and any alternative post-study therapy will be at the descrition of the investigators.

Le traitement avec BST-236 s'arrête à la dernière consolidation. Aucun traitement par BST-236 n'est possible après cette période de traitement et tout autre traitement après cette étude sera à la discrétion des investigateurs.

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

2021-01-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-12

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

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IMP with orphan designation in the indication
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