Clinical Trials Register

Summary
EudraCT Number:	2012-002487-27
Sponsor's Protocol Code Number:	1230.14
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:	2012-12-19
Trial results	View 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

2012-002487-27

A.3

Full title of the trial

A phase III randomised, double-blind, controlled, parallel group study of
intravenous volasertib in combination with subcutaneous low-dose
cytarabine vs. placebo + low-dose cytarabine in patients >= 65 years with
previously untreated acute myeloid leukaemia, who are ineligible for
intensive remission induction therapy.

Studio di fase III, randomizzato, in doppio cieco, controllato, a gruppi paralleli, con volasertib endovena in combinazione con citarabina sottocute a basso dosaggio verso placebo + citarabina a basso dosaggio, in pazienti con eta' >= 65 anni affetti da leucemia mieloide acuta non trattata precedentemente, considerati non eleggibili alla terapia intensiva di induzione della remissione.

A.3.1

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

A study of volasertib in combination with low-dose cytarabine in patients
aged 65 years and above with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy

Studio con volasertib endovena in combinazione con citarabina a basso dosaggio verso placebo + citarabina a basso dosaggio, in pazienti con eta' >= 65 anni affetti da leucemia mieloide acuta non trattata precedentemente, considerati non eleggibili alla terapia intensiva di induzione della remissione.

A.3.2

Name or abbreviated title of the trial where available

POLO-AML-2

A.4.1

Sponsor's protocol code number

1230.14

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	BOEHRINGER ING.
B.1.3.4	Country	Italy
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	Boehringer Ingelheim Italia 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	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+1 800 243 0127
B.5.5	Fax number	+1 800 821 7119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Volasertib
D.3.2	Product code	BI 6727
D.3.4	Pharmaceutical form	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	Volasertib
D.3.9.2	Current sponsor code	BI 6727
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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.2.1.1.1	Trade name	Ara-cell 40 mg injection
D.2.1.1.2	Name of the Marketing Authorisation holder	cell pharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CYTARABINE
D.3.9.1	CAS number	147-94-4
D.3.9.4	EV Substance Code	SUB06880MIG
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

previously untreated acute myeloid leukaemia in patients >= 65 years and ineligible for intensive remission induction therapy

pazienti con eta' >= 65 anni affetti da leucemia mieloide acuta non trattata precedentemente, considerati non eleggibili alla terapia intensiva di induzione della remissione

E.1.1.1

Medical condition in easily understood language

acute myeloid leukaemia (previously untreated) in patients >= 65 years and ineligible for intensive remission induction therapy

pazienti con eta' >= 65 anni affetti da leucemia mieloide acuta non trattata precedentemente, considerati non eleggibili alla terapia intensiva di induzione della remissione

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	10000886
E.1.2	Term	Acute myeloid leukemia
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).

L'obiettivo primario e' valutare l'efficacia di volasertib + citarabina a basso dosaggio in confronto a placebo + citarabina a basso dosaggio in pazienti anziani (>= 65 anni) con LMA precedentemente non trattata e considerati non idonei alla terapia intensiva di induzione della remissione. L'efficacia sara' principalmente valutata in base al tasso di remissione (CR+CRi) e alla sopravvivenza globale (OS).

E.2.2

Secondary objectives of the trial

To investigate the safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy.

Saranno raccolte informazioni aggiuntive rigurdanti la sopravvivenza libera da eventi, la sicurezza, la qualita' di vita correlata allo stato di salute e la farmacocinetica di volasertib + citarabina a basso dosaggio in pazienti anziani (>= 65 anni) con LMA precedentemente non trattata e considerati non idonei alla terapia intensiva di induzione della remissione.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age >= 65years. 2. Cytologically/histologically confirmed AML according to WHO classification; (except for acute promyelocytic leukaemia (APL)). 3. Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for MDS is allowed. 4. Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions). 5. Patient is eligible for LDAC treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance score <= 2 at screening. 7. Signed and dated written informed consent by start date of Screening visit in accordance with GCP and local legislation.

1.Eta' >= 65 anni. 2.LMA con diagnosi citologica/istologica secondo la classificazione WHO; (ad eccezione della leucemia acuta promielocitica (LAP)). 3.LMA precedentemente non trattata (ad eccezione di idrossiurea e/o terapia corticosteroidea per non più di 28 giorni (cumulativi)). 4.Lo sperimentatore ritiene che il paziente non sia idoneo alla terapia intensiva di induzione della remissione, in base a motivazioni mediche documentate (esempio: caratteristiche genetiche della patologia, tipo di LMA (primaria o secondaria) e caratteristiche del paziente quali il punteggio di performance, la presenza di patologie concomitanti e/o di disfunzioni organiche). 5.Paziente eliggibile al trattamento con citarabina a basso dosaggio. 6.Punteggio ECOG (Eastern Co-operative Oncology Group) <= 2 alla visita di screening. 7.Consenso informato firmato e datato in accordo alle GCP e alle normative locali.

E.4

Principal exclusion criteria

1. Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed. 2. Treatment with any investigational drug within 2 weeks before first administration of present trial drug. 3. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3). 4. Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator's judgement is sufficient). 5. Hypersensitivity to one of the trial drugs or the excipients. 6. Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC. 7. QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 ECGs taken at screening. 8. Total bilirubin > 3 x ULN. 9. Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation (see Appendix 10.2 for the formula). 10. Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection. 11. HIV infection. 12. Second malignancy currently requiring active therapy (except for hormonal/antihormonal treatment, e.g. in prostate or breast cancer). 13. Any significant concurrent psychiatric disorder or social situation that according to the investigator's judgement would compromise patient's safety or compliance, interfere with consent, study participation, or interpretation of study results. 14. Known or suspected active alcohol or drug abuse. 15. Patient unable to comply with the protocol, in the opinion of the investigator. 16. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.

1.Precedente o concomitante chemioterapia per LMA (ad eccezione di idrossiurea e/o terapia corticosteroidea per non più di 28 giorni (cumulativi)). 2.Trattamento con altri farmaci sperimentali nelle due settimane precedenti la prima somministrazione del farmaco in studio. 3.Leucemia premielocitica acuta (sottotipo M3 in base alla classificazione French-American-British (FAB)). 4.Presenza di sintomi neurologici che lo sperimentatore ritienga possano essere correlati ad un coinvolgimento leucemico del sistema nervoso centrale (non e' richiesta la puntura lombare; e' sufficiente la valutazione dello sperimentatore in base alle evidenze cliniche). 5.Ipersensibilita' ad uno dei farmaci dello studio o ad un suo eccipiente. 6.Patologie gravi o disfunzioni organiche che coinvolgano cuore, reni, fegato, o altri organi (esempio: infezioni in corso, compromissione della funzionalita' cardiaca clinicamente significativa, grave compromissione cardiaca/insufficienza cardiaca, angina pectoris instabile o storia di un recente infarto miocardico) che, a giudizio dello sperimentatore, precludano al trattamento con citarabina a basso dosaggio. 7.Prolungamento del tratto QTcF > 470 ms o prolungamento del tratto QT, ritenuto clinicamente rilevante dallo sperimentatore (esempio: sindrome congenita del QT lungo). Il QTcF sara' calcolato come la media di tre elettrocardiogrammi effettuati alla visita di screening. 8.Bilirubina totale > 3 volte il limite superiore di normalita'. 9.Clearance della creatinina < 30 mL/min (stimata mediante l'equazione di Cockcroft-Gault (C-G - per la formula vedere l'appendice 10.2 del protocollo). 10.Infezione attiva da epatite B o C, o evidenze di laboratorio di infezione cronica. 11.Infezione da HIV. 12.Patologie maligne secondarie che richiedano una terapia attiva (ad eccezione del trattamento ormonale/anti-ormonale per esempio per il cancro alla prostata o alla mammella). 13.Qualsiasi disordine psichiatrico significativo o situazione sociale concomitanti che, a giudizio dello sperimentatore, possa compromettere la sicurezza o l'aderenza del paziente, interferire con il consenso, la partecipazione allo studio o l'interpretazione dei risultati. 14.Noto o sospetto abuso attivo di alcool e farmaci, in base al giudizio dello sperimentatore. 15.Paziente incapace di aderire al protocollo, in base al giudizio dello sperimentatore. 16.Pazienti maschi con partner in eta' fertile che si rifiutino di utilizzare il preservativo in associazione ad un secondo metodo contraccettivo accettabile dal punto di vista medico per l'intera durata dello studio e per un minimo di 6 mesi dopo il trattamento.

E.5 End points

E.5.1

Primary end point(s)

Complete Remission (CR) and Complete Remission with incomplete blood count recovery (CRi), based on blinded central review.

L'endpoint primario e': -il tasso di remissione completa (CR) e di remissione completa con ripristino incompleto dei parametri ematici (CRi), basandosi su una revisione centralizzata in cieco

E.5.1.1

Timepoint(s) of evaluation of this end point

Response assessment is done at the end of every 2nd cycle during treatment period. In case of suspected disease progression a bone marrow examination should be performed as soon as possible.

La valutazione e' fatta alla fine di ogni secondo ciclo durante il periodo di trattamento. In caso di sospetta progressione della malattia dovrebbe essere eseguito, il piu' presto possibile, un esame del midollo osseo.

E.5.2

Secondary end point(s)

Key secondary endpoint: Overall Survival (OS). Secondary endpoints: Event-Free Survival (EFS), Relapse-Free Survival (RFS), safety (AE), pharmacokinetics (PK)

L'endpoint secondario chiave e': -la sopravvivenza globale (OS). Altri endpoint secondari sono: -la sopravvivenza libera da eventi (EFS); -la sopravvivenza libera da recidiva (RFS); -la sicurezza (AE); -la farmacocinetica (PK);

E.5.2.1

Timepoint(s) of evaluation of this end point

OS: all randomised patients are followed until death, lost to follow-up or withdrawal of consent. EFS: defined for all randomised patients, and measured from date of randomisation to date of progression or relapse, or death, whichever occurs first. RFS: defined only for patients achieving CR or CRi; measured from date of remission until date of relapse or death. Relapse or progression are evaluated at each response assessment. After end of active treatment follow-up visits will occur every 12 weeks. All adverse events occurring during the trial will be collected. Blood for PK will be collected at specified time points during C1 and C2 (optional at C4 and C6).

OS: dalla data di randomizzazione fino al decesso per qualsiasi causa. Per i pazienti che risultano persi al follow-up, OS sara' censorizzata rispetto all'ultima data nota in cui si era a conoscenza che il paziente era in vita. EFS:calcolato dalla data di randomizzazione fino alla data di progressione o recidiva, o decesso per qualsiasi causa, qualunque evento si verifichi per primo. RFS: Definita solo per i pazienti che raggiungono CR o CRi; misurata dalla data della remissione fino alla date della recidiva o del decesso per qualsiasi causa: i pazienti per i quali sono noti l'avvenuta recidiva o il decesso all'ultimo follow up sono censorizzati alla data dell’ultima visita. AE: per tutta la durata della sperimentazione. PK: durante time point C1 e C2 (opzionale C4 e C6).

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker analyses

Analisi Biomarker

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

volasertib+citarabina vs placebo+citarabina

volasertib + cytarabine vs. placebo + cytarabine

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

India

Japan

Korea, Republic of

Mexico

Russian Federation

South Africa

Taiwan

Thailand

United States

Argentina

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The clinical trial will be considered completed as soon as the last patient has died or was lost to follow-up or as the predefined OS events are met.

fino a lost of follow-up o ultimo decesso

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

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)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

770

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

325

F.4.2.2

In the whole clinical trial

770

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)

none

nessuno

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

2013-01-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-14

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

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