Clinical Trials Register

Summary
EudraCT Number:	2010-024264-18
Sponsor's Protocol Code Number:	MT103-205
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:	2012-03-12
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

2010-024264-18

A.3

Full title of the trial

A Single-Arm Multicenter Phase II Study preceded by Dose Evalua-tion to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

Studio multicentrico a singolo braccio di Fase II, preceduto dalla valutazione del dosaggio, per studiare l'efficacia, la sicurezza e la tollerabilita' dell'Anticorpo BiTE Blinatumomab (MT103) in pazienti pediatrici e adolescenti affetti da Leucemia Linfoblastica Acuta (LLA) Pre-B recidivante/refrattaria

A.3.1

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

A combined Pharmacokinetic, Dose-Finding, Safety and Efficacy Study in Pediatric and Adolescent Patients with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Studio combinato di Farmacocinetica, Individuazione della Dose, Sicurezza ed Efficacia in Pazienti in Eta' Pediatrica e Adolescenziale con Leucemia Linfoblastica Acute pre-B (LLA)recidivante/refrattaria

A.4.1

Sponsor's protocol code number

MT103-205

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	MICROMET GMBH
B.1.3.4	Country	Germany
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	Micromet GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Micromet GmbH
B.5.2	Functional name of contact point	Clinical Development Department
B.5.3	Address:
B.5.3.1	Street Address	Staffelseestrasse 2
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	81477
B.5.3.4	Country	Germany
B.5.4	Telephone number	+45 89 8952770
B.5.5	Fax number	+45 89 8952770
B.5.6	E-mail	clinicaltrials@micromet.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/650
D.3 Description of the IMP
D.3.1	Product name	Blinatumomab
D.3.2	Product code	MT103
D.3.4	Pharmaceutical form	Powder and solvent 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	Blinatumomab
D.3.9.1	CAS number	853426-35-4
D.3.9.2	Current sponsor code	MT103
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	33
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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

pediatric and adolescent patients with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after allogeneic HSCT, or refractory to other treatments

pazienti pediatrici e adolescenti con LLA da precursore delle cellule B in seconda o ulteriore recidiva del midollo spinale, in qualsiasi recidiva midollare in seguito a HSCT allogenico oppure refrattari ad altri trattamenti.

E.1.1.1

Medical condition in easily understood language

Acute lymphoblastic leukemia-a cancerof the blood and marrow

Leucemia-a linfoblastica acuta a carico del sangue e del midollo.

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10000845
E.1.2	Term	Acute lymphoblastic leukemia
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 I: To determine the recommended Phase II dose of blinatumomab Phase II: to assess the efficacy of Blinatumomab

Fase I: Determinare la dose di blinatumomab raccomandata per la Fase II Fase II: valutare l'efficacia di Blinatumomab

E.2.2

Secondary objectives of the trial

Phase I:  To assess the safety of different dose levels of blinatumomab in different age groups  To assess pharmacokinetics of different dose levels of blinatumomab in different age groups  To assess the anti-leukemia activity of blinatumomab  To assess the development of anti-drug antibodies (ADA) to blinatumomab  To describe changes in pharmacodynamic markers following treatment with blinatumomab at differing dose levels Phase II:  To assess the safety of blinatumomab  To assess the development of ADA to blinatumomab

Fase I: - Valutare la sicurezza di livelli diversi di dosi di blinatumomab in gruppi di età diversa - Valutare la farmacocinetica di livelli diversi di dosi di blinatumomab in gruppi di età diversa - Valutare la attività anti-leucemica di blinatumomab - Valutare lo sviluppo di anticorpi anti-farmaco (ADA) contro blinatumomab - Descrivere i cambiamenti nei marker farmacodinamici in seguito a trattamento con blinatumomab a differenti livelli di dose Fase II: - Valutare la sicurezza di blinatumomab - Valutare lo sviluppo di ADA contro blinatumomab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Morphologic evidence of B-precursor ALL (pro B-, pre B-, common ALL) with > 25% blasts in bone marrow (M3) 2. Age < 18 years at enrollment [only children age 2-17 will be enrolled prior to the identification of the recommended Phase II dose]. 3. Relapsed/refractory disease: • Second or later bone marrow relapse, • Any marrow relapse after allogeneic HSCT, or • Refractory to other treatments: Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration Patients who have not achieved a first remission must have failed a full standard induction regimen 4. Karnofsky performance status ≥ 50% for patients ≥ 16 years and Lansky Performance Status (LPS) of ≥ 50% for patients < 16 years 5. Organ function requirements: All patients must have a. Creatinine clearance ≥ 70 mL/min/1.73 m2 or a normal serum creatinine based on age/gender b. Adequate liver function defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age OR direct bilirubin ≤ 1.5 mg/DL ALT (SGPT) ≤ 135 IU/L 6. Patient and/or his/her legal representative have reviewed the patient information/informed consent form and have had their questions answered and have given written informed consent

1. Evidenza morfologica di LLA precursore di B (pro B-, pre B-, LLA comune) con > 25% di blasti nel midollo osseo (M3) 2. Età < 18 anni all’arruolamento [saranno arruolati solo bambini in età dai 2 ai 17 anni prima dell’identificazione della dose raccomandata per la Fase II] 3. Malattia recidiva/refrattaria: • Seconda, o più, recidiva del midollo osseo, • Qualsiasi recidiva midollare in seguito a HSCT allogeneico, oppure • Refrattarietà ad altri trattamenti: I pazienti alla prima recidiva devono aver fallito il raggiungimento di una CR in seguito a un pieno regime chemioterapico di reinduzione standard della durata di almeno 4 settimane I pazienti che non hanno raggiunto una prima remissione devono aver fallito un piano di regime di induzione standard 4. Stato di validità secondo Karnofsky ≥ 50% per pazienti ≥ 16 anni d’età e stato di validità secondo Lansky (LPS) di ≥ 50% per pazienti < 16 anni d’età 5. Requisiti di funzionalità organica: Tutti i pazienti devono avere a. Clearance della creatinina ≥ 70 ml/min/1,73 m2 oppure una creatinina sierica normale in base ad età/sesso b. Adeguata funzionalità epatica definita come: Bilirubina totale ≤ 1,5 x limite superiore normale (ULN) per età OPPURE bilirubina diretta ≤ 1,5 mg/DL ALT (SGPT) ≤ 135 IU/l 6. Il paziente e/o il suo rappresentante legale hanno esaminato il modulo di informazione per il paziente/modulo di consenso informato, hanno ricevuto risposte esaurienti alle loro domande e hanno dato consenso informato scritto

E.4

Principal exclusion criteria

1. Active acute or extensive chronic GvHD 2. Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment 3. Evidence for current CNS involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL [patients with CNS relapse at the time of M3 relapse are not eligible for the Phase I part but are eligible for the Phase II part of the study, if CNS is successfully treated prior to enrollment]. Two successive CSF evaluations at least one week apart following completion of CNS therapy that are CNS1 are required 4. History of relevant CNS pathology or current relevant CNS pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) 5. History of autoimmune disease with potential CNS involvement or current autoimmune disease 6. Any HSCT within 3 months prior to blinatumomab treatment 7. Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids) 8. Chemotherapy related toxicities that haven’t resolved to ≤ Grade 2 9. Radiotherapy within 4 weeks prior to blinatumomab treatment 10. Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment 11. Any investigational product within 4 weeks prior to study entry 12. Known hypersensitivity to immune globulins or to any other component of the study drug formulation 13. Presence of HAMA reactivity (in patients with prior exposure to murine antibodies or proteins) 14. Active malignancy other than ALL 15. Active severe infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol An active infection is defined as: a. Positive blood culture within 48 hours of study enrollment b. Fever above 38.2 °C within 48 hours of study enrollment with clinical signs of infection 16. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive) 17. Pregnant or nursing female adolescent patients 18. Post-menarchal female adolescent patients or male adolescent patients not willing to use an effective form of contraception during treatment phase of the study and at least 3 months thereafter. 19. Placed into an institution due to juridical or regulatory ruling

1. GvHD cronica attiva, acuta o estesa 2. Agenti immunosoppressori per prevenire o trattare GvHD nelle 2 settimane che precedono il trattamento con blinatumomab 3. Evidenza di coinvolgimento corrente del SNC causato da LLA (CNS 2, CNS 3) o coinvolgimento testicolare cau-sato da LLA [pazienti con recidiva del SNC al momento della recidiva di M3 non sono eleggibili per la parte della Fase I ma sono eleggibili per la parte della Fase II dello studio, se il SNC è trattato con successo prima dell’arruolamento]. Sono richieste due valutazioni successive del SNC ad almeno una settimana di distanza in seguito al completamento della terapia del SNC che sono SNC1 4. Anamnesi di patologia del SNC importante o malattia importante al SNC in atto (epilessia, paresi, afasia, ische-mica cerebrovascolare/emorragie, gravi lesioni cerebrali, demenza, malattia cerebellare, sindrome cerebrale or-ganica, psicosi, disturbi del movimento o del coordinamento) 5. Anamnesi di malattia autoimmune con potenziale coinvolgimento del SNC o malattia autoimmune in atto 6. Qualsiasi HSCT nei 3 mesi che precedono il trattamento con blinatumomab 7. Chemioterapia per cancro nelle 2 settimane che precedono il trattamento con blinatumomab (a eccezione di chemioterapia intratecale e/o terapia a bassa dose di mantenimento quale alcaloidi della vinca, mercaptopurina, metotressato, glucocorticoidi) 8. Tossicità correlate alla chemioterapia che non sono state risolte al ≤ grado 2 9. Radioterapia nelle 4 settimane che precedono il trattamento con blinatumomab 10. Immunoterapia (ad es., ritusimab, alemtuzumab) nelle 6 settimane che precedono il trattamento con blinatumo-mab 11. Qualsiasi prodotto sperimentale nelle 4 settimane che precedono l’arruolamento nello studio 12. Ipersensibilità nota alle immunoglobuline o a qualsiasi altro componente della formulazione del farmaco in studio 13. Presenza di reattività HAMA (in pazienti con esposizione precedente ad anticorpi o proteine murino) 14. Tumori maligni attivi diversi da LLA 15. Infezione in atto o qualsiasi altra malattia concomitante o condizione medica che si ritiene possa essere esacer-bata dal trattamento o possa interferire seriamente con l’esecuzione del protocollo Un’infezione in atto definita quale: a. Coltura ematica positiva entro 48 ore dall’arruolamento allo studio b. Febbre superiore ai 38,2 °C nelle 48 ore dall’arruolamento allo studio con segni clinici di infezione 16. Infezione nota da virus dell’immunodeficienza umana (HIV) o infezione cronica da virus dell’epatite B (HbsAg positivo) o virus dell’epatite C (anti-HCV positivo) 17. Pazienti di sesso femminile adolescenti in gravidanza o in fase di allattamento al seno 18. Pazienti di sesso femminile adolescenti post-menarca o pazienti di sesso maschile adolescenti non disposti a utilizzare un’efficace forma di contraccezione durante la fase di trattamento dello studio e almeno per i 3 mesi successivi. 19. Situato all’interno di un’istituzione per disposizioni giuridiche o regolatorie

E.5 End points

E.5.1

Primary end point(s)

Phase I Maximal tolerable dose defined by ≤ 1 of 6 patients experiencing dose limiting toxicity (DLT) or maximal adminis-tered dose (MAD) Phase II  Rate of complete remission (CR) within the first 2 cycles

Fase I Dose massima tollerabile definita da ≤ 1 di 6 pazienti che manifestano tossicità dose-limitante (DLT) o dose mas-sima somministrata (MAD) Fase II  Tasso di remissione completa (CR) entro i primi 2 cicli

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase I: In the pahse I part of the study, safety will be assessed by the occurrence of dose limiting toxicity (DLT) within the first 28 days of treatment (cycle 1) Phase II: In the phase II part of the study, efficacy will be assessed by measurement of complete blood count (CBC) and evalutation of a bone marrow will be assessed at D15 of teh first cycle and at the end of teh infusion period (D29, can be delayed until Day 42) of every cycle.

Fase I: Nella parte di fase I dello studio, la sicurezza sarà valutata attraverso la ricorrenza della tossicità dose-limitante (DLT) nei primi 28 giorni di trattamento (ciclo 1) Fase II: Nella parte di fase II dello studio, l'efficacia sarà valutata attraverso il rilevamento della conta cellulare completa (CBC) ed una valutazione del midollo osseoverrà effettuata al giorno 15 del primo ciclo e alla fine del periodo di infusione (il giorno 29 pò essere ritardato fino al giorno 42) di ciascun ciclo.

E.5.2

Secondary end point(s)

Fase I:  Overall incidence and severity of adverse events  Quantification and characterization of pharmacokinetic parameters over time in selected patients  Rate of complete remission (CR) within first 2 cycles  Time to hematological relapse  CR duration  Overall survival (OS)  Relapse free survival  Proportion of patients who develop ADA at any time  Quantification and characterization of cytokine serum concentrations Fase II:  Overall incidence and severity of adverse events  Proportion of patients who undergo allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with blinatumomab  Time to hematological relapse  CR duration  Overall survival (OS)  Relapse free survival  Proportion of patients who develop ADA at any time Exploratory Endpoints (Phase I+II)  Rate of MRD response  Rate of complete MRD response

Fase I:  Incidenza complessiva e gravità degli eventi avversi  Quantificazione e caratterizzazione dei parametri farmacocinetici nel corso del tempo in pazienti selezionati  Tasso di remissione completa (CR) entro i primi 2 cicli  Tempo alla recidiva ematologica  Durata della CR  Sopravvivenza complessiva (OS)  Sopravvivenza libera da recidiva  Proporzione di pazienti che hanno sviluppato ADA in qualsiasi momento  Quantificazione e caratterizzazione delle concentrazioni sieriche della citochina Fase II:  Incidenza complessiva e gravità degli eventi avversi  Proporzione di pazienti che si sottopongono a trapianto di cellule staminali ematopoietiche allogeneiche (HSCT) in seguito a trattamento con blinatumomab  Tempo alla recidiva ematologica  Durata della CR  Sopravvivenza complessiva (OS)  Sopravvivenza libera da recidiva  Proporzione di pazienti che hanno sviluppato ADA in qualsiasi momento Endpoint esplorativi (fase I+II)  Tasso della risposta MRD  Tasso della risposta MRD completa

E.5.2.1

Timepoint(s) of evaluation of this end point

Phase I: 1. Continously 2. D1, 3, 8, 15, 22, 29 (cycle 1 + 2) 3.-7. efficacy will be assessed by measurement of complete blood count (CBC) and evalutation of a bone marrow will be assessed at D15 of teh first cycle and at the end of teh infusion period (D29, can be delayed until Day 42) of every cycle. 8. End of every cycle 9. D1, 2, 3 Phase II: 1.-2. Continously 3.-6. as for 3.-7. Phase I Part 7. End of every cycle Exploratory endpoints (phase I + II): as for 3.-7. Phase I part

Fase I: 1. Continuamente 2. D1, 3, 8, 15, 22, 29 (ciclo 1 + 2) 3-7. L'efficacia sarà valutata attraverso il rilevamento della conta cellulare completa (CBC) ed una valutazione del midollo osseoverrà effettuata al giorno 15 del primo ciclo e alla fine del periodo di infusione (il giorno 29 pò essere ritardato fino al giorno 42) di ciascun ciclo. 8. Fine di ogni ciclo 9. D1, 2, 3 Fase II: 1-2. Continuamente 3.-6. come per 3.-7. della parte di fase I 7. Fine di ciascun ciclo Endpoint esplorativi (fase I+II): come per 3.-7. della parte di Fase I

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

Yes

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

first in children trial

E.7.2

Therapeutic exploratory (Phase II)

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

The end of the trial is defined as the last protocol mandated evaluation for the last patient in the study

La conclusione della sperimentazione è definita come l'ultimo test previsto dal protocollo effettuato sull'ultimo paziente dello studio.

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

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)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Infants and toddlers

Lattanti e bambini piccoli

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)

No specific treatment is planned after trial participation

Nessun trattemnto specifico è previsto dopo al termine della partecipazione allo studio

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

2012-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-06-20

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Clinical trials