Clinical Trials Register

Summary
EudraCT Number:	2014-000608-90
Sponsor's Protocol Code Number:	Eltrombo-IT-2014
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-10-03
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

2014-000608-90

A.3

Full title of the trial

Eltrombopag for inherited thrombocytopenias.

A.3.1

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

Evaluation of safety and efficacy of eltrombopag in increasing platelet count and reducing bleeding tendency of patients with different forms of inherited thrombocytopenia.

Valutazione della tollerabilità ed efficacia del farmaco eltrombopag nell’incrementare la conta piastrinica e ridurre il sanguinamento dei pazienti affetti da diverse forme di piastrinopenia ereditaria.

A.4.1

Sponsor's protocol code number

Eltrombo-IT-2014

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 IRCCS Policlinico San Matteo
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	GLAXOSMITHKLINE 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 IRCCS Policlinico San Matteo
B.5.2	Functional name of contact point	Medicina Generale III
B.5.3	Address:
B.5.3.1	Street Address	P.le Golgi 19
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0382501358
B.5.5	Fax number	+390382526223
B.5.6	E-mail	alessandro.pecci@unipv.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	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	Eltrombopag 12.5 mg
D.3.2	Product code	NA
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	ELTROMBOPAG OLAMINE
D.3.9.1	CAS number	496775-62-3
D.3.9.3	Other descriptive name	ELTROMBOPAG OLAMINE
D.3.9.4	EV Substance Code	SUB30141
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	12.5
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	Yes
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	Eltrombopag 25 mg
D.3.2	Product code	NA
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	ELTROMBOPAG OLAMINE
D.3.9.1	CAS number	496775-62-3
D.3.9.3	Other descriptive name	ELTROMBOPAG OLAMINE
D.3.9.4	EV Substance Code	SUB30141
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	25
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.2.5	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	Eltrombopag 50 mg
D.3.2	Product code	NA
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	ELTROMBOPAG OLAMINE
D.3.9.1	CAS number	496775-62-3
D.3.9.3	Other descriptive name	ELTROMBOPAG OLAMINE
D.3.9.4	EV Substance Code	SUB30141
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.3.11 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

Inherited thrombocytopenias

Piastrinopenia ereditaria

E.1.1.1

Medical condition in easily understood language

Inherited thrombocytopenias are a group of diseases characterized by a reduced platelet count due to mutation in specific genes and bleeding tendency that ranges from life-threatening to mild.

Le piastrinopenie ereditarie sono un gruppo di disordini caratterizzati da riduzione della conta piastrinica dovuta a mutazione di specifici geni e conseguente diatesi emorragica di varia gravità.

E.1.1.2

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	HLT
E.1.2	Classification code	10043555
E.1.2	Term	Thrombocytopenias
E.1.2	System Organ Class	100000004851

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

Phase 1
To ascertain whether and in which forms of inherited thrombocytopenia eltrombopag can be used to transiently increase platelet count over 100 x 109/L and to abolish bleeding tendency.
Phase 2
To verify whether and in which forms of inherited thrombocytopenia eltrombopag can be used to stably reduce bleeding tendency in patients with clinical significant bleedings and who had their bleeding tendency reduced during Phase 1 of the study.

Fase 1: testare se, e in quali forme di piastrinopenia ereditaria, eltrombopag può essere utilizzato per incrementare transitoriamente la conta piastrinica oltre 100 x109/L e abolire la diatesi emorragica.
Fase 2: testare se, e in quali forme di piastrinopenia ereditaria, eltrombopag può essere utilizzato per ridurre stabilmente il sanguinamento spontaneo nei pazienti con diatesi emorragica spontanea che hanno ottenuto una riduzione transitoria del sanguinamento al termine della Fase 1 dello studio.

E.2.2

Secondary objectives of the trial

Phases 1 and 2
- Evaluate safety and tolerability of Eltrombopag in patients with inherited thrombocytopenias.
- Identify the dosages of Eltrombopag required to obtain the primary objectives of Phases 1 and 2.

Fasi 1 e 2:
- Valutare sicurezza e tollerabilità del trattamento con eltrombopag nei pazienti con piastrinopenia ereditaria.
- Identificare il dosaggio minimo di eltrombopag necessario per l’ottenimento degli obiettivi primari delle Fasi 1 e 2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Phase 1
Patients with the following forms of inherited thrombocytopenias will be considered for enrolment:
- MYH9-related disorders (OMIM 155100, 605249, 153640, 153650)
- Bernard-Soulier Syndrome (OMIM 231200) deriving from monoallelic mutations (at variance with biallelic classical BSS, monoallelic form does not present defective platelet function)
- Wiskott-Aldrich syndrome (OMIM 301000).
- X-linked thrombocytopenia (OMIM 313900).
- X-linked thrombocytopenia with thalassemia (OMIM 314050).
- Dyserythropoietic anemia with thrombocytopenia (OMIM 300367).
- ITGA2B/ITGB3-related thrombocytopenia (OMIM not available).
- ANKRD26-related thrombocytopenia (OMIM 188000).
- TUBB1-related thrombocytopenia (OMIM not available)
- ACTN1-related thrombocytopenia (OMIM not available)
- GFI1B-related thrombocytopenia (OMIM not available)
Patients will have to fulfill all the following criteria:
- Age ≥ 16 years and ≤ 70 years
- Average platelet count during the previous year less than 80 x109/L
- Written informed consent

Phase 2
Patients with clinically relevant chronic or recurrent bleedings at baseline (grade 2-4 of the WHO bleeding scale) who: (i) completed the phase 1 without severe side effects and (ii) obtained reduction or remission of bleeding by Eltrombopag administration.

Fase 1:
Saranno arruolabili i pazienti affetti dalle seguenti forme di piastrinopenia ereditaria:
- Malattia MYH9-correlata (OMIM 155100, 605249, 153640, 153650).
- Sindrome di Bernard-Soulier (OMIM 231200), monoallelica o biallelica.
- Sindrome di Wiskott-Aldrich (OMIM 301000).
- Piastrinopenia legata all’X (OMIM 313900).
- Piastrinopenia legata all’X con talassemia (OMIM 314050).
- Anemia diseritropoietica con piastrinopenia (OMIM 300367).
- Piastrinopenia da mutazioni di ITGA2B/ITGB3 (OMIM non disponibile).
- Piastrinopenia da mutazioni di ANKRD26 (OMIM 188000).
- Piastrinopenia da mutazioni di TUBB1 (OMIM non disponibile).
- Piastrinopenia da mutazioni di ACTN1 (OMIM non disponibile).
- Piastrinopenia da mutazioni di GFI1B (OMIM non disponibile).
I pazienti dovranno inoltre soddisfare i seguenti criteri:
- Età compresa fra 16 e 70 anni (pari o superiore a 16 anni, pari o inferiore a 70 anni)
- Conta piastrinica media nell’anno precedente inferiore a 80 x 109/L
- Rilascio di consenso informato scritto per l’arruolamento allo studio

Fase 2:
Pazienti con sanguinamento spontaneo cronico o ricorrente clinicamente rilevante (grado 2-4 del bleeding score secondo WHO) che: (a) hanno completato la Fase 1 senza effetti collaterali rilevanti e (b) hanno ottenuto una remissione parziale o totale della diatesi emorragica in seguito all’assunzione di eltrombopag.

E.4

Principal exclusion criteria

Phases 1 and 2
-Hypersensitivity to Eltrombopag or one of the excipients.
- History of thromboembolic events.
- Treatment with anti-platelet drugs or other drugs affecting platelet function and/or with anticoagulants.
- Concurrent diseases or conditions that significantly increase the risk of thromboembolic events, including: malignancies, congestive heart failure (NYHA Grade III/IV), atrial fibrillation or other arrhythmias that predispose to thromboembolic events, known hereditary factors predisposing to venous thromboembolism (factor V mutations, factor II mutations, deficiency of antithrombin III, or protein C, or protein S), antiphospholipid syndrome, hormone replacement therapy and systemic contraception containing estrogen, severe obesity, severe hypertension not controlled by treatment, heavy smoking, diabetes mellitus not controlled by therapy or complicated, severe dislipidemia, haemoglobinopathies increasing the risk of thrombotic events, such as sickle cell anemia or thalassemia major.
- Moderate to severe liver failure (Child-Pugh score ≥ 5).
- Altered renal function as defined by creatinine ≥ 2 mg/dL
- Previous or concurrent clonal disorders of the myeloid series (acute myeloid leukemias and myelodysplastic syndromes).
- Females who are pregnant or nursing (a negative pregnancy test is required before enrolment of fertile women).
- Formal refusal of any recommendations for a safe contraception.
- Alcohol or drug addiction.
- Any other disease or condition that by the advice of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for this study, including physical, psychiatric, social and behavioral problems.

Fasi 1 e 2:
- Ipersensibilità ad Eltrombopag o ad uno degli eccipienti.
- Anamnesi positiva per eventi tromboembolici.
- Concomitante terapia cronica con antiaggreganti piastrinici o altri farmaci che interferiscono con la funzione piastrinica e/o concomitante terapia anticoagulante.
- Patologie o condizioni concomitanti che aumentano in maniera significativa il rischio di eventi tromboembolici, inclusi: neoplasia maligna, scompenso cardiaco congestizio classe NYHA III/IV, fibrillazione atriale o altre artimie cardiache che predispongono al tromboembolismo, fattori ereditari noti che predispongono al tromboembolismo venoso (mutazioni fattore V, mutazioni fattore II, deficit di antitrombina III, deficit di proteina C, deficit di proteina S), sindrome da anticorpi anti-fosfolipidi, terapia contraccettiva comprendente estrogeni o terapia ormonale sostitutiva, obesità grave, ipertensione arteriosa non controllata dalla terapia, tabagismo grave, diabete mellito non controllato dalla terapia o complicato, dislipidemia grave, severa, emoglobinopatie ad aumentato rischio trombotico come la anemia falciforme o la talassemia major.
- Insufficienza epatica da moderata a grave (punteggio Child-Pugh ≥ 5).
- Insufficienza renale con creatininemia ≥ 2 mg/dL.
- Patologie clonali della serie mieloide (leucemie acute mieloidi e sindromi mielodisplastiche) in atto o pregresse.
- Gravidanza o allattamento (per le pazienti di sesso femminile in età fertile è richiesto test di gravidanza negativo all’arruolamento).
- Rifiuto formale di adottare metodi di contraccezione sicura durante lo studio.
- Alcoolismo o abuso di droghe
- Preesistenza di qualsiasi altra condizione o patologia per cui, a giudizio del medico sperimentatore, il trattamento previsto sia pericoloso per il paziente e/o renda il paziente ineleggibile a questa sperimentazione clinica, inclusi problemi fisici, psichiatrici, sociali e comportamentali.

E.5 End points

E.5.1

Primary end point(s)

Phase 1: Platelet counts higher than 100 x 109/L and no bleeding events (Grade 0 of WHO bleeding scale) during the last week of treatment.

Phase 2: Long term reduction of bleeding tendency as measured by the WHO bleeding scale.

Fase 1: raggiungimento di una conta piastrinica superiore a 100 x109/L e assenza di diatesi emorragica spontanea (grado 0 del bleeding score secondo WHO) durante l’ultima settimana di trattamento.

Fase 2: riduzione a lungo termine della tendenza al sanguinamento in termini di riduzione del bleeding score secondo WHO

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase 1: last week of treatment
Phase 2: end of study

Fase 1: ultima settimana di trattamento
Fase 2: fine studio

E.5.2

Secondary end point(s)

- Dosages of eltrombopag required for achieving the primary endpoints of Phases 1 and 2.
- Ability to receive the programmed treatment with eltrombopag without side effects requiring drug discontinuation

Exploratory Endpoints:
Effect of treatment on serum thrombopoietin (TPO) level, number of reticulated platelets, in vitro platelet aggregation.

- Identificazione del dosaggio minimo di eltrombopag necessario per l’ottenimento degli endpoints primari delle Fasi 1 e 2.
- Capacità di ricevere il trattamento previsto di accedere senza la comparsa di effetti collaterali che richiedano la sospensione della terapia.

Endpoints esplorativi:
Valutazione dell’effetto del trattamento su alcuni parametri biologici legati alla produzione ed alla funzione delle piastrine: livelli sierici di trombopoietina, numero di piastrine reticolate, aggregazione piastrinica in vitro.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of study

Fine studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Effects of treatment on biological parameters.

Effetti del trattamento sui parametri biologici

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

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

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

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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)

Not provided

Non previsto

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

2014-12-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-15

P. End of Trial
P.	End of Trial Status	Completed

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