Clinical Trials Register

Summary
EudraCT Number:	2018-003542-17
Sponsor's Protocol Code Number:	FISM_IRON-MDS
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-05-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-003542-17

A.3

Full title of the trial

Early and low dose Deferasirox (3.5 mg/kg FCT) to suppress NTBI and LPI as early intervention to prevent tissue iron overload in lower risk MDS

Dose bassa e precoce di Deferasirox ( 3.5 mg/kg FCT) per sopprimere NTBI e LPI come intervento precoce per prevenire il danno tessutale da sovraccarico di ferro nelle MDS a basso rischio

A.3.1

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

Early and low dose Deferasirox (3.5 mg/kg FCT) to suppress NTBI and LPI as early intervention to prevent tissue iron overload in lower risk MDS

Dose bassa e precoce di Deferasirox ( 3.5 mg/kg FCT) per sopprimere NTBI e LPI come intervento precoce per prevenire il danno tessutale da sovraccarico di ferro nelle MDS a basso rischio

A.3.2

Name or abbreviated title of the trial where available

FISM_IRON-MDS

A.4.1

Sponsor's protocol code number

FISM_IRON-MDS

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	FONDAZIONE ITALIANA SINDROMI MIELODISPLASTICHE ETS
B.1.3.4	Country	Italy
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	Novartis Farma S.p.A.
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	Fondazione Italiana Sindromi Mielodisplastiche Onlus
B.5.2	Functional name of contact point	Segreteria
B.5.3	Address:
B.5.3.1	Street Address	Largo Brambilla 3
B.5.3.2	Town/ city	Firenze
B.5.3.3	Post code	50134
B.5.3.4	Country	Italy
B.5.6	E-mail	segreteria@fismonlus.it

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	EXJADE - 180 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTERS PVC/PVDC/ALLUMINIO - 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Exjade
D.3.2	Product code	[Agenti chelanti del ferro]
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	DEFERASIROX
D.3.9.1	CAS number	201530-41-8
D.3.9.2	Current sponsor code	IMP1
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3500
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	Yes
D.3.11.13.1	Other medicinal product type	Agente chelante del ferro

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

Adult patients with low risk MDS

Pazienti adulti affetti da Mielodisplasia a basso grado

E.1.1.1

Medical condition in easily understood language

Adult patients with low risk MDS

Pazienti adulti affetti da Mielodisplasia a basso grado

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	LLT
E.1.2	Classification code	10028532
E.1.2	Term	Myelodysplasia
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

Balance iron burden in one-year treatment in early phase of transfusion requirement by low dose (3.5 mg/kg) DFX-FCT (prevention of iron overload) as demonstrated by hepatic iron concentration.

Bilanciamento del carico di ferro in un anno di trattamento nella fase iniziale del fabbisogno trasfusionale mediante DFX-FCT a basso dosaggio (3,5 mg / kg) (prevenzione del sovraccarico di ferro) come dimostrato dalla concentrazione epatica del ferro.

E.2.2

Secondary objectives of the trial

1) Definition of iron overload (including serological markers and MRI definition of iron loading in liver, tissue reactive iron species and oxidative stress in MDS at beginning of transfusional history
2) Efficacy
3) On year evolution of iron overload serologic markers
4) Presence and quantitative evolution of toxic serum iron forms (iron tissue reactive species) under low dose DFX therapy
5) Verify if regular suppression of the “free iron forms” prevent accumulation of tissue iron
6) Evaluate the overall safety of deferasirox FCT formulation in patients with lower risk MDS at the beginning of their transfusional history
7) Leukemic transformation (including progression to leukemia or higher rIPSS scores)
8) Hemopoietic response
9) Costs analysis
10) Study of biological cellular damage by iron toxicity before and during treatment

1) Definizione del sovraccarico di ferro (inclusi marcatori sierologici e definizione dell' MRI del carico di ferro nel fegato, specie reattive tissutali di ferro e stress ossidativo nella MDS all'inizio della storia trasfusionale
2) Efficacia
3) Evoluzione annuale dei marcatori sierologici con sovraccarico di ferro
4) Presenza e evoluzione quantitativa delle forme di ferro sierico tossico (specie reattive tissutali di ferro) sotto terapia con DFX a basso dosaggio
5) Verificare se la soppressione regolare delle "forme di ferro libere" impedisce l'accumulo di ferro tissutale
6) Valutare la sicurezza complessiva delle compresse rivestite del deferasirox in pazienti con MDS a basso rischio all'inizio del loro storia trasfusionale
7) Trasformazione leucemica ( inclusa la progressione a leucemia o score di rischio RIPSS più alto)
8) Risposta emopoietica
9) Analisi dei costi
10) Studio del danno biologico cellulare dovuto alla tossicità del ferro prima e dopo il trattamento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Diagnosis: Adult Myelodysplastic Syndrome (=18 years)
2) Revised IPSS: very low. low – intermediate
3) Having received 5-20 packed red blood cell units
4) Serum ferritin =300 ng/ml
5) Transferrin saturation =60%
6) Chelation naïve
7) Capability to provide informed consent

1) Diagnosi: Adulti affetti da sindrome mielodisplastica (=18 anni)
2) Revised IPSS: molto vasso, basso, intermedio
3) Aver ricevuto 5-20 sacche di globuli rossi
4) Ferritina sierica =300 ng/ml
5) Saturazione della transferrina =60%
6) Pazienti non già sottoposti a chelazione
7) Capacità di fornire il consenso informato

E.4

Principal exclusion criteria

1) Patients aged <18 years old
2) Higher risk (revised IPSS) MDS (Intermediate 2, high)
3) Cumulative transfusion story of > 20 packed red cell units
4) Creatinine Clearance (CrCL): <60 ml/min. Patients with CrCl of 40-60ml/min will be included only individually if no other renal risk factors are present
5) Serum creatinine >2 x ULN at screening. If borderline serum creatinine will be measured within 7-10 days and the mean value will be used for eligibility criteria
6) Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample (or alternatively in two of three samples obtained for screening)
7) ECOG performance status >2.
8) Left ventricular ejection fraction < 50% by echocardiograph
9) A history of repeated hospitalization for congestive heart failure.
10) Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
11) Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of chronic hepatitis follows EASL 2017 criteria)
12) History of HIV positive test result (ELISA or Western blot)
13) Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start.
14) ALT or AST over 3 times superior to ULN at screening
15) ANC < 500/ microL
16) Platelets transfusion dependency
17) Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study)
18) Diagnosis of Child score C liver cirrhosis
19) Patients participating in another clinical trial other than an observational registry study
20) Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
21) History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative
22) Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
23) Pregnant, intending-to-become pregnant, or breast-feeding patients
24) History of drug or alcohol abuse within the 12 months prior to enrollment
25) Inability to provide a valid informed consent

1) Pazienti di età <18 anni
2) MDS ad alto rischio secondo lo score r-IPSS ( rischio intermedio 2, alto)
3) Storia trasfusionale cumulativa > 20 sacche di globuli rossi
4) Clearence della Creatinina ( CrCL): <60 ml/min. I pazienti con Crcl di 40-60ml/min saranno inclusi solo se non sono presenti altri fattori di rischio renale
5) Creatinina sierica>2 x ULN allo screening. Se il valore della creatinina sierica è al limite, sarà misurato entro 7-10 giorni e lo stesso valore sarà utilizzato per i criteri di eleggibilità
6) Significativa proteinuria come indicato dalla proteina urinaria/creatinina ratio > 0.5 mg/mg in un campione di urina non del primo getto ( o in alternativa in due o tre campioni ottenuti per lo screening)
7) ECOG performance status >2.
8) Frazione di eiezione ventricolare sinistra <50% stabilita mediante ecocardiografo
9) Una storia di ospedalizzazioni ripetute per insufficienza cardiaca congestizia
10) Malattie sistemiche che impedirebbero il trattamento previsto dallo studio (ad es. ipertensione non controllata, malattia cardiovascolare, renale, epatica, metabolica, ecc.)
11) Evidenza clinica o di laboratorio di Epatite B o Epatite C croniche ( la definizione dell'epatite cronica segue i criteri EASL 2017)
12) Storia di test HIV positivi ( ELISA e Western blot)
13) Trattamento con farmaci sperimentali sistemici entro 4 settimane o farmaci sperimantali topici entro 7 giorni dall'inizio dello studio
14) allo screening ALT o AST oltre 3 volte superiori al limite superiore del valore normale
15) ANC < 500/ microL
16) Dipendenza da trasfusioni di piastrine
17) Allo screening Bilirubina totale oltre 1,5 volte superiore al limite superiore del valore normale (i pazienti con sindrome di Gilbert possono entrare nello studio)
18) Diagnosi di cirrosi epatica con score Child C
19) Paziente che partecipa ad un'altra sperimentazione clinica diversa da uno studio osservazionale di registro
20) Pazienti con una storia di un'altra neoplasia negli ultimi 3 anni, ad eccezione del carcinoma basale della pelle o del collo dell'utero, carcinoma in situ o polipi colonici completamente asportati, carcinoma in situ.
21) Storia di mancato rispetto delle indicazioni mediche o pazienti che sono considerati potenzialmente inaffidabili e / o non cooperativi
22) Presenza di una condizione chirurgica o medica che potrebbe alterare in modo significativo l'assorbimento, la distribuzione, il metabolismo o l'escrezione del farmaco in studio
23) Pazienti incinte, con l'intenzione di restare incinte o che allattano
24) Storia di droghe o abuso di alcool nei 12 mesi precedenti l'arruolamento
25) Incapacità a fornire un valido consenso informato

E.5 End points

E.5.1

Primary end point(s)

Change of hepatic iron from the baseline according to baseline hepatic iron level:
For patients with baseline LIC = 5 mg/g dry weight (dw) ± 1.5 mg/g dw.
For patients with baseline LIC >5 mg/g dw ±20% as demonstrated by R2- MRI (test performed in a 1.5 tesla MRI machine and analyzed following R2 method – Baseline versus EOS.
The corresponding secondary efficacy variable will be the absolute change in hepatic iron concentration EOS versus baseline.

Modifica del ferro epatico dal baseline secondo i livelli di ferro epatico del baseline:
Per i pazienti con baseline LIC = 5 mg/g dry weight (dw) ± 1.5 mg/g dw.
Per i pazienti con baseline LIC >5 mg/g dw ±20% come dimostrato da R2-MRI ( test eseguito in una macchina MRI a 1.5 tesla e analizzato seguendo il metodo R2 - Baseline versus EOS

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year

1 anno

E.5.2

Secondary end point(s)

Absolute change in hepatic iron concentration EOS versus baseline.; Absolute and relative changes in serum ferritin and transferrin saturation from baseline to every visit during the whole treatment period.; Proportion of patients with NTBI > normal values and/or LPI > normal values at end of study vs baseline.
Changes in NTBI and LPI from baseline to every visit during the whole treatment period.; Cost and outcome with low dose in early chelation vs. chelation treatment in MDS patients with transfusional iron overload in accordance with either local or international guidelines; MDA values during the study and relationship to NTBI and LPI values; Proportion of patients with a disease progression (progression defined as a transition into a higher MDS risk group based on revised IPSS scoring or progression to AML)
Time to progression (defined as above) or to leukemia transformation.; Percentage of patients with hematologic improvements in term of erythroid response following IWG 2006 criteria.
Time to reach transfusion dependence defined as > 2 PRBC units/months for 3 months for patients with pre-transfusional Hb < 9.0 g/dl (or <10 g/dl for patients with cardiac disease) or a total number of PRBC units received = 20 from baseline.
Absolute reticulocytes count from baseline to every visit during the whole treatment period.
Absolute values and evolution of serum transferrin receptor, GDF11, GDF15 and erythroferrone from baseline to every visit during the whole treatment period.
Evaluation of transfusional ratio: number of units received in a predetermined period/ mean pretransfusional Hb level. Compared with other studies on general population (study and FISM registry).
Patients receiving concurrent rHuEpo and other disease modifying agents will not be considered for hemopoietic response.; Overall safety, as measured by frequency and severity of reported AEs and SAEs and changes in laboratory values from baseline: serum creatinine, creatinine clearance ALT, AST, complete blood count (platelets, RBC and
WBC) and total direct and indirect bilirubin).; Absolute values of serum ferritin, transferrin saturation, NTBI, LPI, liver MRI and oxidative stress at baseline.; Relationship between NTBI and LPI with serum ferritin and liver and pancreas iron overload (MRI) at end of study versus baseline

Cambiamento assoluto nella concentrazione epatica del ferro al termine dello studio rispetto al basale.; Cambiamenti assoluti e relativi nella ferritina sierica e nella saturazione della transferrina dal basale ad ogni visita durante l'intero periodo di trattamento.; Proporzione dei pazienti con NTBI> i valori normali e/o LPI> valori normali alla fine dello studio rispetto al baseline.
Modifiche di NTBI e LPI dal baseline ad ogni visita durante l'intero periodo di trattamento.; Costi ed outcome con la chelazione precoce a basse dosi rispetto al trattamento ferrochelante in pazienti affetti da mielodisplasia con sovraccarico trasfusionale di ferro secondo le linee guida locali o internazionali.; Valori dell'MDA durante lo studio e relazione con i valori di NTBI e LPI; Proporzioen dei pazienti con una progressione di malattia ( progressione definita come passaggio a un gruppo di rischio della mielodisplasia più alto secondo il punteggio dell'r-IPSS o progressione a leucemia mieloide acuta).
Tempo alla progressione ( definito come sopra) e alla trasformazione in leucemia.; Percentuale dei pazienti con miglioramento ematologico in termini di risposta eritroide secondo i criteri IWG 2006.
Tempo per raggiungere la trafusione dipendenza definito come >2 sacche di globuli rossi/mese per 3 mesi per i pazienti con emoglobina pretrasfusionale < 9.0 g/dl (o <10 g/dl per i pazienti con patologia cardiaca) o un numero totale di sacche di globuli rosse ricevute = 20 dal baseline.
Conta assoluta dei reticolociti dal baseline per ogni visita durante l'intero periodo di trattamento.
Valori assoluti ed evoluzione del recettore della transferrina sierica, GDF11, GDF15 ed eritroferrone dal baseline per ogni visita durante l'intero periodo di trattamento.
Valutazione del rapporto trasfusionale: numero delle unità ricevute in un periodo predeterminato/livello medio di emoglobina pretrasfusionale. Comparazione con altri studi sulla popolazione generale ( studi e registro FISM).
Pazienti che ricevono concomitante rHuEpo o altri agenti che modificano la risposta alla malattia non saranno considerati per la risposta emopoietica.; Sicurezza generale, misurata dalla frequenza e gravità degli eventi avversi segnalati e dalla modifica dei valori di laboratorio dal baseline: creatinina sierica, clearance della creatinina, ALT, AST, emocromo completo ( piastrine, globuli rossi e bianchi) e bilirubina totale diretta e indiretta.; Valori assoluti di ferritina sierica, saturazione della transferrina, NTBI, LPI, MRI del fegato e stress ossidativo al basale; Relazione tra NTBI e LPI e la ferritina sierica e il sovraccarico di ferro del fegato e del pancreas ( MRI) alla fine dello studio rispetto al baseline

E.5.2.1

Timepoint(s) of evaluation of this end point

1 year; 1 year; 1 year; 1 year; 1 year; 1 year; 1 year; 1 year; 1 year; 1 year

1 anno; 1 anno; 1 anno; 1 anno; 1 anno; 1 anno; 1 anno; 1 anno; 1 anno; 1 anno

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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

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

Information not present in EudraCT

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:

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

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)

At the end of the trial the patients will be followed according to the normal clinical practice

Al termine della sperimentazione i pazienti verranno seguitI secondo quanto previsto dalla normale pratica clinica

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

2019-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-06

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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