Clinical Trials Register

Summary
EudraCT Number:	2010-021162-30
Sponsor's Protocol Code Number:	WIL-24
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-03-07
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

2010-021162-30

A.3

Full title of the trial

Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Disease (VWD) Who Undergo Major Surgical Procedures.

Sperimentazione clinica prospettica, aperta, multicentrica di fase III, per la valutazione dell`™efficacia e della sicurezza del concentrato di fattore VWF/VIII (Wilate) umano in soggetti affetti da malattia di Von Willebrand (VWD) di tipo 3 ereditaria sottoposti a interventi chirurgici maggiori.

A.3.1

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

Clinical trial to test if the study drug is safe and if it works well in severe Type 3 von Willebrand patients that need to have a major surgery.

Sperimentazione clinica per valutare la sicurezza e l’efficacia del farmaco in pazienti affetti da malattia di von Willebrand grave di tipo 3, che necessitano di un intervento chirurgico maggiore.

A.3.2

Name or abbreviated title of the trial where available

WIL-24

A.4.1

Sponsor's protocol code number

WIL-24

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	OCTAPHARMA AG
B.1.3.4	Country	Switzerland
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	Octapharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Premier Research Group srl
B.5.2	Functional name of contact point	Start-up
B.5.3	Address:
B.5.3.1	Street Address	Via Winckelmann 2
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20146
B.5.3.4	Country	Italy
B.5.4	Telephone number	0248958768
B.5.5	Fax number	0248958776
B.5.6	E-mail	stefania.giovanelli@premier-research.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	Wilate 500 I.U.
D.3.2	Product code	Wilate 500 I.U.
D.3.4	Pharmaceutical form	Powder for solution for injection
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	Wilate
D.3.9.3	Other descriptive name	Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII)
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
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	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	Wilate 1000 I.U.
D.3.2	Product code	Wilate 1000 I.U.
D.3.4	Pharmaceutical form	Powder for solution for injection
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	Wilate
D.3.9.3	Other descriptive name	Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII)
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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	Yes
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

Surgery in Inherited Von Willebrand Disease (VWD)

Interventi chirurgici nella malattia ereditaria di Von Willebrand

E.1.1.1

Medical condition in easily understood language

Interventi chirurgici nella malattia ereditaria di Von Willebrand

Surgery in Inherited Von Willebrand Disease (VWD)

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10047715
E.1.2	Term	Von Willebrand's disease
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

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

The primary objective of the study is to evaluate the overall hemostatic efficacy of Wilate in preventing excessive intra- and post-operative bleeding in pediatric and adult subjects with Type 3 VWD who require a Von Willebrand Factor (VWF) product and undergo a major surgical procedure.

Obiettivo primario della sperimentazione è valutare l’efficacia emostatica complessiva di Wilate nella prevenzione dell’emorragia eccessiva intra- e post-operatoria in soggetti adulti e in età pediatrica affetti da VWD di Tipo 3 che necessitano di Fattore di Von Willebrand (VWF) e sottoposti a intervento chirurgico maggiore.

E.2.2

Secondary objectives of the trial

To evaluate the intra- and post-operative surgical hemostatic efficacy of Wilate in preventing excessive bleeding in pediatric and adult subjects with Type 3 VWD who require a VWF product and undergo a major surgical procedure. :
• To assess the safety of Wilate used in Type 3 VWD subjects who undergo major surgical procedures.
• To document the capability of Wilate to normalize the coagulation defect in VWD as demonstrated by an increase of the plasma activity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) and Factor VIII:Coagulant (FVIII:C).
• To analyze the actual dosage and duration of treatment in surgical procedures.

•Valutare l’efficacia emostatica intra- e post-operatoria di Wilate nella prevenzione dell’emorragia eccessiva in soggetti adulti e in età pediatrica affetti da VWD di Tipo 3 che necessitano di Fattore di Von Willebrand (VWF) e vengono sottoposti a intervento chirurgico maggiore.
•Valutare la sicurezza di Wilate in soggetti affetti da VWD di Tipo 3 sottoposti a interventi chirurgici maggiori.
•Documentare la capacità di Wilate di normalizzare il difetto di coagulazione in
pazienti affetti da VWD, come dimostrato da un aumento di attività plasmatica del cofattore Ristocetina del fattore di Willebrand (VWF:RCo) e del Fattore VIII di coagulazione (FVIII:C).
•Analizzare il dosaggio effettivo e la durata del trattamento nelle procedure chirurgiche.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male and female subjects who are at least 6 years of age.
2. Diagnosed with Type 3 VWD where VWF:RCo and VWF:Ag are <1% or below detection limit of the assay at screening or the subject has a diagnosis of Type 3 VWD and a history of VWF:RCo and/or VWF:Ag are < 1% or below detection limit of the assay documented in their medical notes at enrolment.
3. Require therapy with a VWF product to treat any potential major surgical procedure.
4. Negative for anti-human immunodeficiency virus (HIV); if positive, viral load <200 particles/μL or <400,000 copies/mL and CD4+ count > 200/μL.
5. The subject and/or their legally acceptable representative understands the nature of the study, gives written informed consent to participate in the study and is willing and able to comply with the protocol.

1. Soggetti maschi e femmine di età non inferiore ai 6 anni.
2. Soggetti con diagnosi di VWD di Tipo 3 in cui VWF:RCo e VWF:Ag sono <1% o al di sotto del limite di rilevazione dell’analisi allo screening, ovvero soggetti con diagnosi di VWD di Tipo 3 e un’anamnesi di VWF:RCo e/o di VWF:Ag < 1% o al di sotto del limite di rilevazione dell’analisi, come documentato dalle note cliniche redatte all’atto dell’arruolamento.
3. Necessitano di terapia con un prodotto a base di VWF per il trattamento di eventuali emorragie nel corso di interventi chirurgici maggiori.
4. Negativi al virus dell’immunodeficienza umana (HIV); se positivi, con carica virale <200 particelle /uL o <400.000 copie/mL e conta CD4+ > 200/uL.
5. Il soggetto e/o il suo rappresentante legalmente riconosciuto comprende la natura dello studio, fornisce il consenso informato scritto alla partecipazione al medesimo, e infine è disposto ad attenersi al protocollo ed è in grado di farlo.

E.4

Principal exclusion criteria

1. Known coagulation disorder other than congenital Type 3 VWD.
2. Any VWF containing product administered within 3 days prior to the screening visit.
3. Any subject where it is planned to infuse the investigational product via continuous infusion.
4. Have a known history of, or are suspected to have VWF or FVIII inhibitors.
5. Emergency surgery or any surgery with a degree of urgency not permitting completion of baseline assessment required by the study protocol.
6. Suffering an acute or chronic medical condition, other than VWD, which may in the opinion of the Investigator affect the conduct of the study.
7. Subjects with active hepatic disease (ALT or AST levels > 5 times the upper limit of normal)
8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Wilate or other VWF/FVIII concentrates.
9. Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs at study start.
10. Pregnant women within the first 20 weeks of gestation.
11. Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit.
12. Participation in another interventional clinical study currently or during the past 4 weeks.

1. Malattie della coagulazione note diverse da VWD di Tipo 3 congenito
2. Soggetti a cui è stato somministrato un prodotto a base di VWF nei 3 giorni precedenti la visita di screening.
3. Soggetti cui si prevede di somministrare il prodotto oggetto della sperimentazione tramite infusione continua.
4. Soggetti con un’anamnesi positiva per la presenza di inibitori del VWF o del FVIII o con sospetta presenza di inibitori del VWF o del FVIII.
5. Intervento chirurgico di emergenza o intervento chirurgico con un livello d’urgenza tale da non permettere l’esecuzione di una valutazione di base completa come previsto dal protocollo di studio.
6. Soggetti affetti da una patologia acuta o cronica, diversa dalla VWD, che possa a giudizio dello Sperimentatore compromettere la conduzione dello studio.
7. Soggetti con epatopatia attiva (livelli di ALT o AST > 5 volte il limite superiore dell’intervallo di riferimento).
8. Soggetti con ipersensibilità nota o sospetta o con precedente evidenza di gravi effetti collaterali al Wilate o ad altri concentrati di VWF/FVIII.
9. Soggetti sotto terapia con farmaci immunomodulanti (diversi dalla chemioterapia antiretrovirale) quali alfa-interferone, prednisone (equivalente a >10 mg/g),
o farmaci analoghi all’inizio dello studio.
10. Donne gravide entro le prime 20 settimane di gestazione.
11. Soggetti con evidenze cliniche o anamnesi (entro i precedenti 12 mesi) di abuso di sostanze lecite o illecite.
12. Partecipazione ad un altra sperimentazione clinica interventistico concomitante o nelle 4 settimane precedenti.

E.5 End points

E.5.1

Primary end point(s)

Overall hemostatic efficacy (success or failure) of Wilate in the treatment in Type 3 VWD subjects who undergo a major surgical procedure, based on both the intra-operative assessment of the surgeon and the assessment by the Investigator covering the post-surgical period from the end of the procedure to 24 hours following the last infusion, both of which use a 4-point ordinal efficacy scale. The overall efficacy is assessed according to a pre-defined algorithm.

Efficacia emostatica complessiva (successo o fallimento) di Wilate nel trattamento dei soggetti affetti da VWD di Tipo 3 sottoposti a interventi chirurgici maggiori, sulla base sia della valutazione intra-operatoria del chirurgo sia della valutazione dello Sperimentatore responsabile del periodo post-chirurgico, dal termine della procedura a 24 ore dopo l’ultima infusione, entrambe classificate su una scala di efficacia ordinale a 4punti. L’efficacia complessiva viene valutata in base a un algoritmo predefinito.

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall hemostatic efficacy of Wilate in the treatment in Type 3 VWD subjects who undergo a major surgical procedure, based on both the intra-operative assessment of the surgeon and the assessment by the Investigator covering the post-surgical period from the end of the procedure to 24 hours following the last infusion.

Efficacia emostatica complessiva di Wilate nel trattamento dei soggetti affetti da VWD di Tipo 3 sottoposti a interventi chirurgici maggiori, sulla base sia della valutazione intra-operatoria del chirurgo sia della valutazione dello Sperimentatore responsabile del periodo post-chirurgico, dal termine della procedura a 24 ore dopo l’ultima infusione.

E.5.2

Secondary end point(s)

• Assessment of intra-operative hemostatic efficacy according to 4-point ordinalefficacy scales.
• Assessment of post-operative hemostatic efficacy according to 4-point ordinal efficacy scales.
• Documentation of the actual dosage and duration of treatment during surgical procedures.
• Measurement of VWF:RCo and FVIII:C plasma activity during treatment.
• The nature and incidence of adverse events (AE).
• Assessment of the in vivo recovery (IVR) of VWF:RCo, VWF:Ag, and FVIII:C.

• Valutazione dell’efficacia emostatica intra-operatoria in base a scale ordinali di efficacia a 4 punti
• Valutazione dell’efficacia emostatica post-operatoria in base a scale ordinali di efficacia a 4 punti
• Documentazione del dosaggio effettivo e durata del trattamento durante la procedura chirurgica.
• Misurazione delle attività plasmatiche di VWF:RCo e FVIII:C durante il trattamento.
• Natura e incidenza degli eventi avversi (EA).
• Valutazione del recupero in vivo (IVR) di VWF:RCo, VWF:Ag, e FVIII:C.

E.5.2.1

Timepoint(s) of evaluation of this end point

• The intra-operative efficacy of Wilate during the surgical procedures will be assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure (last suture).
• Documentation of the actual dosage and duration of treatment during surgical procedures will be assessed during full course of treatment.
• Measurement of VWF:RCo and FVIII:C plasma activity during treatment will be assessed during full course of treatment.
• The nature and incidence of adverse events (AE) will be assessed at the end of the study.
• Assessment of the in vivo recovery (IVR) of VWF:RCo, VWF:Ag, and FVIII:C will be calculated at baseline from samples obtained pre infusion, 0,5 and 1 hour post-infusion.

• L'efficacia intra-operatoria durante l'intervento chirurgico sarà valutata in base a scale ordinali di efficacia a 4 punti alla fine dell'intervento (ultima sutura)
• Documentazione del dosaggio effettivo e durata del trattamento durante la procedura chirurgica alla fine dell'intervento (ultima sutura)
• Misurazione delle attività plasmatiche di VWF:RCo e FVIII:C durante il trattamento.
• Natura e incidenza degli eventi avversi (EA) alla fine dello studio.
• Valutazione del recupero in vivo (IVR) di VWF:RCo, VWF:Ag, e FVIII:C saranno calcolati al basale dai campioni ottenuti pre-infusione, 0,5 e 1 ora post-infusione.

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

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

India

Russian Federation

Turkey

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

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)

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)

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-07.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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

The subject and/or their legally acceptable repr.understands the nature of the study, gives written IC to participate in the study and is willing and able to comply with the protocol

Il soggetto e/o il suo legale rappr.,capisce la natura dello studio, dà il suo consenso scritto per partecipare ed è disp.e capace di aderire

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)

Standard care treatmet is planned after the patient has ended the participation in the trial.

E' previsto il trattamento standard alla fine 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

2011-06-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-04-08

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