Clinical Trials Register

Summary
EudraCT Number:	2010-024631-16
Sponsor's Protocol Code Number:	EFC10260
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:	2011-09-01
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

2010-024631-16

A.3

Full title of the trial

A Phase 2, Multi-Center, Double-Blind, placebo controlled, Randomized Study of Ombrabulin in Patients with Platinum-Sensitive Recurrent Ovarian Cancer treated with Carboplatin/Paclitaxel

Studio multicentrico, in doppio cieco, controllato verso placebo, randomizzato di fase II, di Ombrabulin in associazione a Carboplatino/Paclitaxel in pazienti con recidiva di carcinoma ovarico platino-sensibile

A.3.1

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

A Phase 2, Multi-Center, Double-Blind, placebo controlled, Randomized Study of Ombrabulin in Patients with Platinum-Sensitive Recurrent Ovarian Cancer treated with Carboplatin/Paclitaxel

studio di ombrabulin/placebo in associazione carboplatino/paclitaxel in pazienti con tumore ovarico ricorrente e sensibile al platino

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

EFC10260

A.5.4

Other Identifiers

Name:

Number:

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	SANOFI-AVENTIS S.P.A
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	sanofi-aventis recherche & de'veloppement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi-aventis recherche & de'veloppement
B.5.2	Functional name of contact point	Serv. Inform. Sper Clin.
B.5.3	Address:
B.5.3.1	Street Address	1 Avenue Pierre Brossolette
B.5.3.2	Town/ city	Chilly-Mazarin
B.5.3.3	Post code	91385
B.5.3.4	Country	France
B.5.4	Telephone number	+33 169 74 59 97
B.5.5	Fax number	+33 169 74 57 30
B.5.6	E-mail	Contact-us@sanofi-aventis.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	OMBRABULIN
D.3.2	Product code	AVE8062
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ombrabulin
D.3.9.2	Current sponsor code	AVE8062
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	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.2.1.1.1	Trade name	TAXOL 100*INF MULT 100MG+COLL
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB Srl
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.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	6
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.2.1.1.1	Trade name	CARBOPLATINO TEVA*IV 450MG45ML
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA PHARMA ITALIA Srl
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.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carboplatino
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	10
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	Concentrate for 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

Ovarian Cancer

Tumore ovarico

E.1.1.1

Medical condition in easily understood language

Ovarian Cancer

tumore delle ovaie

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10066697
E.1.2	Term	Ovarian cancer recurrent
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate an improvement in Progression-Free Survival (PFS) for ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin

• Dimostrare un miglioramento del Tempo di Sopravvivenza Libera da Progressione (PFS) a seguito del trattamento con Ombrabulin verso placebo in associazione a Carboplatino/Paclitaxel, in pazienti con recidiva di carcinoma ovarico platino-sensibile (OC).

E.2.2

Secondary objectives of the trial

To compare the overall survival (OS) between the 2 treatment arms To compare the objective response rate (RR) between the 2 treatment arms

•Confrontare la sopravvivenza globale (OS) nei due bracci di trattamento. •Confrontare il tasso di risposta obiettivo (RR) nei due bracci di trattamento.

E.2.3

Trial contains a sub-study

Yes

E.3

Principal inclusion criteria

Signed informed consent. 2. At least 18 years of age. 3. Histological and/or cytological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma. 4. Completion of maximum one previous line of chemotherapy containing a platinum agent. Neoadjuvant/adjuvant treatment that include a surgical procedure will be considered as one line if platinum-based. 5. Documented sensitivity to a platinum-based chemotherapy regimen. “Platinum-sensitivity” is defined by a radiologic relapse more than 6 months after last dose of platinumbased chemotherapy. 6. Measurable progressive disease: Measurable disease (as defined by RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm³ when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >15 mm in short axis when measured by CT or MRI. In case of a single measurable lesion, this should not be previously irradiated. 7. ECOG performance status ≤2 8. Life expectancy more than 12 weeks

1.Consenso informato firmato. 2.Età maggiore o uguale a 18 anni. 3.Diagnosi istologica e/o citologica di carcinoma epiteliale ovarico, carcinoma alle tube di Falloppio o carcinoma peritoneale primario. 4.Completamento di massimo una precedente linea chemioterapica contenente platino. Il trattamento neoadiuvante/adiuvante che include una procedura chirurgica sarà considerato una linea se a base di platino. 5.Documentata sensibilità ad un regime chemioterapico a base di platino. La “sensibilità al platino” è definita come recidiva di malattia occorsa più di 6 mesi dopo l’ultima somministrazione di chemioterapia a base di platino. 6.Malattia misurabile: La malattia è definita misurabile (in accordo ai criteri RECIST 1.1) se costituita da almeno una lesione che possa essere accuratamente misurata in almeno una dimensione (deve essere registrato il diametro più lungo). Ogni lesione deve essere di almeno 10 mm se misurata mediante tomografia computerizzata (CT) o risonanza magnetica (MRI). I linfonodi, se misurati con CT o MRI, dovranno avere l’asse minore di una lunghezza superiore a 15 mm. Nel caso in cui si abbia una singola lesione misurabile, questa non deve essere stata precedentemente irradiata. 7.ECOG performance status <o uguale a 2 8.Aspettativa di vita maggiore di 12 settimane.

E.4

Principal exclusion criteria

1. History of uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis. 2. History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed. 3. Participation in another clinical trial and any concurrent treatment with any investigational drug or anti-tumor therapy or radiotherapy within 21 days prior to randomization (or 28 days for those therapies with a schedule of administration every 4 weeks and exception for nitrosoureas, mitomycin which may not be used up to 6 weeks prior to the first cycle provided that patients do not have residual signs of any toxicity). No wash-out is required for hormonotherapy that has to be discontinued before the first cycle. 4. Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results. 5. Pregnancy or breast-feeding. Positive serum or urine pregnancy test prior to randomization. 6. Patient with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of “effective method of contraception” will be based on the investigator’s judgment. Effective method of contraception should also be adapted to local regulations. 7. Inadequate organ function including: neutrophils <1.5 x 10^9/L; platelets <100 x 10^9/L; creatinine ≥ 1.5 ULN. If creatinine ≥ ULN, the calculated creatinine clearance should be ≥ 60 ml/min (as per Cockroft Formula). Total bilirubin not within normal limit and ALT/AST/AP >2.5 times the upper normal limits of the institutional norms. An increase of AP up to grade 2 would be accepted only if this increase is related to the presence of bone metastases. Bone specific isoenzyme AP should be evaluated. 8. Urine protein-creatinin ratio (UPCR) >1 (urinanalysis on morning spot urine) or proteinuria >500 mg/24h 9. Pre-existing peripheral neuropathy > grade 1 according to the NCI CTCAE V.4.03 10. Pre-existing hearing impairment > grade 1 11. Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound/excipients of the study drug combination 12. Discontinuation of previous treatment with paclitaxel and/or carboplatin for toxicity reason 13. Other serious illness or medical conditions such as (but not restricted): - Active infection - Superior vena cava syndrome - Pericardial effusion requiring intervention (drainage) 14. Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thrombo-embolism within the past 6 months still requiring anticoagulants. 15. Cardiac Troponin at levels that exceed the normal ranges values defined by the laboratory 16. Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension. 17. Patient with LVEF value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography 18. 12-lead ECG: - Infarction Q-wave, - ST segment depression or elevation ≥1 mm in at least 2 contiguous leads

1.Storia di metastasi cerebrali non controllate, compressione spinale, o meningite carcinomatosa. 2.Storia di altre neoplasie con esclusione del carcinoma cutaneo basocellulare e squamocellulare adeguatamente trattati, del carcinoma in situ della cervice e qualsiasi altro tumore per il quale il paziente sia stato libero da malattia per un periodo superiore a 5 anni. 3.Partecipazione ad altri studi clinici e qualsiasi trattamento concomitante con i farmaci sperimentali o terapia antitumorale o radioterapia nei 21 giorni precedenti la randomizzazione (o 28 giorni nel caso di terapie con schemi di somministrazione quadri-settimanali; con l’eccezione per la nitrosurea e per la mitomicina che non potranno essere somministrati entro 6 settimane dal primo ciclo di trattamento fermo restando che i pazienti non abbiano sintomi residui di tossicità). L’ormonoterapia non necessita di un periodo di wash-out ma deve essere interrotta prima della somministrazione del ciclo 1. 4.Qualsiasi condizione clinica grave (acuta o cronica), che potrebbe avere un impatto sulla partecipazione del paziente nello studio o interferire con l’interpretazione dei risultati dello studio. 5.Donne in gravidanza o in allattamento. Test di gravidanza positivo (nel siero o nelle urine) precedente la randomizzazione. 6.Pazienti fertili che, durante il periodo di trattamento e per almeno i 3 mesi successivi al termine del trattamento, non acconsentano all’utilizzo di un metodo contraccettivo riconosciuto ed efficace. La scelta di un “metodo contraccettivo efficace” verrà lasciata al giudizio dello Sperimentatore e dovrà essere conforme alle normative locali. 7.Funzione d’organo inadeguata: neutrofili < 1,5 x 109/L; piastrine < 100 x 109/L; creatinina > 1,5 ULN. In caso di creatinina > o uguale ULN, la clearance della creatinina calcolata dovrà essere >o uguale a 60 ml/min (calcolata secondo la formula di Cockroft; Appendice E). Bilirubina totale non entro i limiti di normalità, e ALT/AST/AP > 2.5 UNL E’ accettabile un aumento della fosfatasi alcalina sino al grado 2 solo se tale aumento sia correlato alla presenza di metastasi ossee. In questo caso dovranno essere valutati gli isoenzimi della fosfatasi alcalina specifici per l’osso. 8.Rapporto delle proteinuria sulla creatinuria (UPCR) >1 (analizzato sullo spot urinario del mattino) o proteinuria >500 mg/24h. 9.Pre-esistente neuropatia periferica > di grado 1 in accordo con NCI CTCAE V.4.03 10.Pre-esistente danno all’udito > di grado 1 11.Nota ipersensibilità ai taxani e/o al polisorbato 80 o ad ogni altro componente/eccipiente della combinazione dei farmaci in studio. 12.Interruzione di precedenti trattamenti con paclitaxel e/o carboplatino per motivi di tossicità. 13.Altre gravi condizioni cliniche o patologie quali (ma non limitate a): -Infezioni in atto -Sindrome della vena cava superiore -Effusione pericardica che richieda intervento (drenaggio). 14.Anamnesi documentata di infarto del miocardio, angina pectoris, aritmie (in particolare gravi disturbi della conduzione quali blocco atrioventricolare di secondo o terzo grado), ictus o anamnesi di tromboembolismo arterioso o venoso entro gli ultimi 6 mesi per i quali sia ancora necessario somministrare farmaci anticoagulanti. 15.Troponina cardiaca a livelli superiori rispetto al limite superiore di normalità definito dal laboratorio. 16.Pazienti con ipertensione non controllata, entro i 3 mesi precedenti il trattamento in studio o pazienti con danni d’organo secondari ad ipertensione. 17.Pazienti con frazione di eiezione ventricolare sinistra (LVEF) valutata mediante ecocardiografia o angiocardiografia, minore del limite inferiore di normalità del centro. 18.Elettrocardiogramma (ECG) a 12 der. - infarto Q -sotto o sopra-slivellamento del segmento ST > o uguale a 1 mm in almeno 2 derivazioni contingue

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS)

Tempo di Sopravvivenza Libera da Progressione (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

aproximately 24 months

circa 24 mesi

E.5.2

Secondary end point(s)

Overall Survival (OS) Objective Response Rate (RR)

-Sopravvivenza Globale (OS) -tasso di Risposta Oggettiva (RR)

E.5.2.1

Timepoint(s) of evaluation of this end point

aproximately 24 months

circa 24 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Information not present in EudraCT

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

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

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.8.5.1

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

Russian Federation

Switzerland

Ukraine

United States

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

Information not present in EudraCT

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

130

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

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

106

F.4.2.2

In the whole clinical trial

150

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
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-07-09

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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