Clinical Trials Register

Summary
EudraCT Number:	2010-019501-41
Sponsor's Protocol Code Number:	MPD-RC112
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-01-31
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-019501-41

A.3

Full title of the trial

Randomized Trial of Pegylated Interferon Alfa-2a versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera and High Risk Essential Thrombocythemia

Studio Randomizzato che compara la terapia con Interferone Alfa-2a Peghilato rispetto alla terapia con Idrossiurea nel trattamento di pazienti Policitemia Vera ad alto rischio e Trombocitemia Essenziale ad alto rischio

A.3.1

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

Trial to compare the responses in two strata of patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia. Each patient will receive PEGASYS (Pegylated Interferon Alfa-2a) or Hydroxyurea (also known as Hydroxycarbamide). The treatment assigned will be chosen by chance.

Studio che compara l'efficacia di due diverse terapie in pazienti affetti da Policitemia Vera o Trombocitemia Essenziale. I trattamenti in questione sono il PEGASYS (Interferone Alfa-2 peghilato) e l'Idrossiurea (conosciuto anche come Idrossicarbamide) ed entrambi saranno assegnati in maniera casuale.

A.3.2

Name or abbreviated title of the trial where available

PEGHU-Phase3

A.4.1

Sponsor's protocol code number

MPD-RC112

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01259856

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	CONSORZIO MARIO NEGRI SUD
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Myeloproliferative Disorders Research Consortium
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CONSORZIO MARIO NEGRI SUD
B.5.2	Functional name of contact point	Laboratory of Clinical Epidemiology
B.5.3	Address:
B.5.3.1	Street Address	via Nazionale 8/A
B.5.3.2	Town/ city	Santa Maria Imbaro (Chieti)
B.5.3.3	Post code	66030
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0872 570250
B.5.5	Fax number	+39 0872 570206
B.5.6	E-mail	mpdrc@negrisud.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Peginterferon PFS
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Basel
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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	PEGINTERFERON ALFA-2A
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	180
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)	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	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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	ONCOCARBIDE*20CPS 500MG
D.2.1.1.2	Name of the Marketing Authorisation holder	TEOFARMA 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	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IDROXICARBAMIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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	Yes
D.3.11.13.1	Other medicinal product type	prodotto di emisintesi

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

High Risk Polycythemia Vera or High Risk Essential Thrombocythemia

Policitemia Vera ad alto rischio e Trombocitemia Essenziale ad alto rischio

E.1.1.1

Medical condition in easily understood language

Patients with Polycythemia Vera or Essential Thrombocythemia

Pazienti affetti da policitemia vera o da trombocitemia essenziale

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	10036057
E.1.2	Term	Polycythaemia vera
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10015493
E.1.2	Term	Essential thrombocythaemia
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 compare the complete hematologic response rates (by LeukemiaNet Criteria) in patients randomized to treatment with the Pegylated Interferon Alfa-2a (PEGASYS) vs. Hydroxyurea in two strata of patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia. All comparisons will be carried out separately within each disease stratum.

Confrontare il numero di Risposte Complete (CR) dei pazienti trattati con Interferone Alfa-2 Peghilato vs. pazienti trattai con Idrossiurea (vedi LeukemiaNet Criteria) in due gruppi separati di pazienti: 1) Pazienti con PV ad alto rischio e 2) pazienti con ET ad alto rischio (stratificati per malattia).

E.2.2

Secondary objectives of the trial

-toxicity, safety and tolerability of therapy. -hematologic partial response rates on therapy. -specific pre-defined toxicity and tolerance of therapy and validate the utility of sequential structured symptom assessment package of patient reported outcome instruments. -impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) to impact key biomarkers of the disease. -survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation. -incidence of major cardiovascular events.

-tossicità e tollerabilità della terpia (Pegasys vs. Idrossiurea). -numero di Risposte Parziali (PR) secondo i criteri LeukemiaNet (Pegasys vs. Idrossiurea). -impatto della terapia (Pegasys vs. Idrossiurea) sui biomarkers chiave della patologia. -Valutare specifiche pre-definite tossicità e tolleranza alla terapia (Pegasys vs. Idorssiurea) attraverso l’accertamento sequenziale di una serie di sintomi costitutivi del paziente indicativi dell’esito. -sopravvivenza e incidenza dello sviluppo della sindrome mielodisplastica, mielofibrosi o trasformazione in leucemia. -l'incidenza dei maggiori eventi cardiovascolari.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria: High risk PV ANY ONE of the following: Age >60 years Previous documented thrombosis, erythromelalgia or migraine either after diagnosis or within 10 years before diagnosis and considered to be disease related Significant (i.e. > 5cm below costal margin on palpation) or symptomatic (pain, early satiety) splenomegaly Platelets > 1000 x 109/L Diabetes or hypertension requiring pharmacological therapy High risk ET ANY ONE of the following factors: Age > 60 years Platelet count > 1500 x 109/L Previous thrombosis Previous hemorrhage related to ET Diabetes or hypertension requiring pharmacological therapy Other Inclusion criteria Diagnosed less than 3 years prior to entry on trial Never treated with cytoreductive drugs except hydroxyurea for up to 3 months maximum (phlebotomy, aspirin allowed) Age: > 18 years (no upper limit) Ability and willingness to comply with all study requirements Signed informed consent to participate in this study. Willing to participate in associated correlative science biomarker study

Criteri di Inclusione Policitemia Vera ad alto rischio (uno dei seguenti): - Età > 60 anni - Pregressa trombosi documentata, eritromelalgia o emicrania presenti dopo la diagnosi oppure nei 10 anni precedenti la diagnosi e che siano correlati alla patologia. - Splenomegalia significativa (es. > 5 cm dal margine costale alla palpazione) o sintomatica (dolore, sazietà precoce) - Piastrine > 1000x10(9)/L - Diabete o ipertensione che richedono una terapia farmacologica Trombocitemia Essenziale ad alto rischio (uno dei seguenti): - Età > 60 anni - Piastrine > 1500x10(9)/L - Trombosi pregressa - Pregressa emorragia correlata alla ET - Diabete o ipertensione che richedono una terapia farmacologica Altri criteri di inclusione - Diagnosi risalente a non più di 3 anni prima dell'inclusione nel trial - Nessun trattamento con farmaci citoriduttivi fatta eccezione per l'idrossiurea per un periodo massimo di 3 mesi (sono consentiti i salassi e l'assunzione di l'aspirina) - Età > 18 anni - Capacità e disponibilità ad aderire a tutte le richieste dello studio - Firma del consenso informato scritto - Disponibilità a partecipare allo studio biologico associato

E.4

Principal exclusion criteria

Exclusion criteria: (ANY of) Any contraindications to pegylated interferon or hydroxyurea Presence of any life-threatening co-morbidity History of active substance or alcohol abuse within the last year Subjects who are pregnant, lactating or of reproductive potential and not practicing an effective means of contraception History of psychiatric disorder (e.g. depression) History of autoimmune disorder (e.g. hepatitis) Hypersensitivity to IFN-α HIV, HBV, or systemic infection Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension) History or other evidence of decompensated liver disease Splanchnic vein thrombosis (includes Budd-Chiari, portal vein, splenic and mesenteric thrombosis) History or other evidence of chronic pulmonary disease associated with functional limitation Thyroid dysfunction not adequately controlled Any investigational drug <6 weeks prior to the first dose of study drug Neutrophil count <1.5 x 109/L JAK2 exon 12 mutation Patients should not meet criteria for post PV or post ET-MF (see appendix B) No previous exposure to any formulation of pegylated interferon Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment.

Criteri di esclusione (uno dei seguenti) - Qualunque controindicazione al trattamento con idrossiurea o con interferone Alfa-2 peghilato - Presenza di fattori di comorbidità che mettono a rischio la vita del paziente - Storia di abuso di alcol o droghe nell’ultimo anno - Donne incinte, che allattano o potenzialmente in gravidanza, non protette da quest’ultima mediante metodo di contraccezione accettato - Storia di malattie psichiatriche (es. depressione) - Storia di malattie autoimmunutarie (es. epatite) - Ipersensibilità al INF-a - Positività all’HIV-HBV o altre infezioni sistemiche - Evidenze di grave retinopatia (es. retinite da CMV. Degenerazione della macula) o disordini oftalmologici clinicamente rilevanti (es. dovuti a diabete mellito o ipertensione) - Storia o altre evidenze di patologia epatica scompensata - Trombosi venosa splancnica (incluse sindrome di Budd-Chiari, vena portale, trombosi splenica o mesenterica) - Storia o altre evidenze di malattia cronica polmonare associata a limitazioni funzionali - Disfunzioni tiroidee non adeguatamente controllate - Trattamenti con farmaci sperimentali meno di 6 settimane prima dall’assunzione della prima dose di farmaco - Neutrofili < 1,5x10(9)/L - Mutazione nell’esone 12 del gene JAK2 - Pazienti che non possiedono i criteri di diagnosi di PV o ET-MF (vedi appendice B) - Nessuna precedente esposizione all’interferone peghilato - Soggetti con altre condizioni mediche che secondo l’opinione del medico potrebbero compromettere i risultati dello studio per effetti deleteri del trattamento

E.5 End points

E.5.1

Primary end point(s)

Complete Response. Criteria for complete response in ET: -Platelet count </= 400 x 109/L AND -No disease-related symptoms* AND -Normal spleen size on imaging AND -WBC </= 10 x 109/L Criteria for complete response in PV: -Hematocrit <0.45 without phlebotomy AND -Platelet count < 400 x 109/L AND -WBC > 10 x 109/L AND -Normal spleen size on imaging AND -No disease related symptoms

Risposta Completa clinico-ematologica. Nella Trombocitemia Essenziale la risposta completa (RC) viene definita da un numero di piastrine inferiore o uguale a 400 x 109/L, da assenza di sintomi relati alla malattia, da assenza di splenomegalia e da un numero di globuli bianchi inferiore o uguale a 10 x 109/L. Nella Policitemia Vera la risposta completa è definita da un ematocrito inferiore al 45% (senza flebotomia), da un numero di piastrine inferiore o uguale a 400 x 109/L, un numero di globuli bianchi inferiore o uguale a 10 x 109/L, da assenza di splenomegalia e da assenza di sintomi relati alla malattia

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

-To compare the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) in the study populations. -To compare the hematologic partial response rates on therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) by LeukemiaNet criteria. -To compare specific pre-defined toxicity and tolerance of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) and validate the utility of sequential structured symptom assessment package of patient reported outcome instruments. -To compare the impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) to impact key biomarkers of the disease(s) – JAK2-V617F, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities. -To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea). -To estimate incidence of major cardiovascular events (defined as cardiovascular death, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, Budd Chiari syndrome, deep vein thrombosis, and any other clinically relevant thrombotic event) after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).

-Valutare la tossicità e la tollerabilità della terpia (Pegasys vs. Idrossiurea) nella popolazione in studio. -Valutare il numero di Risposte Parziali (PR) secondo i criteri LeukemiaNet (Pegasys vs. Idrossiurea). -Misurare l'impatto della terapia (Pegasys vs. Idrossiurea) sui biomarkers chiave della patologia - JAK2V617F includendo la quantificazione delle mutazioni a carico degli alleli JAk e cMPL, la clonalità delle cellule ematopoietiche nelle piastrine e nei granulociti nelle donne, istopatologia del midollo osseo e anomalie citogenetiche. -Valutare specifiche pre-definite tossicità e tolleranza alla terapia (Pegasys vs. Idorssiurea) attraverso l’accertamento sequenziale di una serie di sintomi costitutivi del paziente indicativi dell’esito. -Misurare la sopravvivenza e l'incidenza dello sviluppo della sindrome mielodisplastica, mielofibrosi o trasformazione in leucemia in seguito alla terapia (Pegasys vs. Idrossiurea). -Misurare l'incidenza dei maggiori eventi cardiovascolari (definiti come morte cardiovascoalre, infarto del miocardio, ictus, attacco ischemico transitorio, embolia polmonare, sindrome di Budd Chiari, trombosi venosa profonda e ogni altro evento trombotico clinicamente rilevante) in seguito alla terapia (Pegasys vs. Idrossiurea).

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Canada

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

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)

Yes

F.1.2.1

Number of subjects for this age range:

408

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

204

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

285

F.4.2.2

In the whole clinical trial

612

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)

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Myeloproliferative Disorders Research Consortium (MPD-RC)

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-02-15

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	Ongoing

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