Clinical Trials Register

Summary
EudraCT Number:	2010-020803-63
Sponsor's Protocol Code Number:	AB07015
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-04
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2010-020803-63

A.3

Full title of the trial

A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids

Prospektívna, multicentrická, randomizovaná, dvojito zaslepená, placebom riadená, o dvoch paralelných skupinách, štúdia fázy III pre porovnanie účinnosti a bezpečnosti masitinibu v dávke 6 mg/kg/deň oproti placebu pri liečení pacientov s ťažkou pretrvávajúcou astmou liečenou orálnymi kortikosteroidmi

A.3.1

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

A.4.1

Sponsor's protocol code number

AB07015

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	AB Science
B.1.3.4	Country	France
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	masitinib
D.3.2	Product code	AB1010
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Severe Persistent Asthma

Ťažká pretrvávajúca astma

E.1.1.1

Medical condition in easily understood language

Severe Persistent Asthma

Ťažká pretrvávajúca astma

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.
Primary endpoint: Asthma exacerbation rate (severe and moderate exacerbations) at 36 weeks adjusted on the available person-time (time to end of treatment)

Cieľom štúdie je porovnanie účinnosti a bezpečnosti masitinibu v dávke 6mg/kg /deň oproti placebu pri liečbe pacientov s ťažkou pretrvávajúcou astmou liečenou orálnymi kortikosteroidmi.
Primárny cieľ: Počet ťažkých a stredne ťažkých exacerbácií astmy v 36 týždňoch priradených k individuálnej dobe liečby (doba do konca liečby)

E.2.2

Secondary objectives of the trial

• Asthma Control Questionnaire (ACQ) Score at 12, 20, 28 and 36 weeks
• Moderate and severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
• Severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
• Time to first asthma exacerbation (severe or moderate)
• Percentage of patient experiencing at least one exacerbation at 12, 20, 28 and 36 weeks
• Asthma symptom score at all time points
• Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow between 25-75% of FVC (FEF25-75) at 12, 20, 28 and 36 weeks
• Morning and evening Peak Expiratory Flow Rate (PEFR) at 12, 20, 28 and 36 weeks
• Use of rescue medication for asthma at 12, 20, 28 and 36 weeks
• Quality of Life assessment: AQLQ score at each visit at 12, 20, 28 and 36 weeks

• Dotazník kontroly astmy (ACQ) stav v 12, 20, 28 a 36 týždni
• Počet stredne ťažkých a ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Počet ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Doba do prvej exacerbácie astmy (ťažká alebo stredne ťažká)
• Percento pacientov s výskytom najmenej jednej exacerbácie astmy v 12, 20, 28 a 36 týždni
• Skóre výskytu symptómov astmy vo všetkých časových bodoch
• Usilovný výdychový objem v prvej sekunde (FEV1), usilovná vitálna kapacita (FVC), prietok pri usilovnom výdychu medzi 25-75% z FVC (FEF25-75) v 12, 20, 28 a 36 týždni
• Ranný a večerný vrcholný výdychový prietok (PEFR) v 12, 20, 28 a 36 týždni
• Použitie záchrannej medikácie pre astmu v 12, 20, 28 a 36 týždni
• Hodnotenie kvality života: AQLQ stav pri každej návšteve v 12, 20, 28 a 36 týždni

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient with Severe Persistent Asthma and already treated with oral corticosteroids at a minimal daily dose of 5 mg prednisone or equivalent for at least 3 months prior to screening visit
2. Patient with history of asthma ≥ 1 year prior to screening visit who also meet the following criteria:
o baseline FEV1 ≥ 35 to ≤ 80% of the predicted normal value, demonstrated at least 6 hours after short-acting beta-2-agonist or 12 hours after long-acting beta-2-agonist
o at least 2 asthma exacerbations within one year prior to screening visit including one severe asthma exacerbation as per protocol definition
o uncontrolled asthma
3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
4. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
5. Patient with normal organ function defined as:
o Absolute neutrophil count (ANC) ≥ 2.0 x 109/L
o Haemoglobin ≥ 10 g/dL
o Platelets (PTL) ≥ 100 x 109/L
o AST/ALT ≤ 2.5x ULN
o Bilirubin ≤ 1.5x ULN
o Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
o Albumin > 1 LLN
o Urea ≤ 1.5 x ULN
o Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria ≥ 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
6. Male or female patient older than 18 years
7. Patient weight > 45 kg and BMI > 18 kg/m²
8. Male or female patient of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
9. Patient able and willing to comply with study procedures as per protocol;
10. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
11. Patient affiliated to a social security regimen

1. Pacient s ťažkou pretrvávajúcou astmou a už liečený orálnymi kortikosteroidmi v minimálnej dennej dávke 5 mg prednisónu nebo ekvivalentu najmenej 3 mesiace pred screeningovou návštevou
2. Pacient s históriou astmy ≥1 rok pred screeningovou návštevou, ktorý tiež musí splňovať následujúce kritériá:
o baseline FEV1 ≥ 35 až ≤ 80% z predpokladanej normálnej hodnoty, preukázanej najmenej 6 hodín po podaní krátko pôsobiacich β-2-agonistov alebo 12 hodín po podaní dlho pôsobiacich β-2-agonistov
o najmenej 2 exacerbácie astmy behom jedného roku pred screeningovou návštevou včetne jednej exacerbácie ťažkej astmy ako je definované protokolom
o nekontrolovaná astma
3. Pacient s nesignifikantnou zmenou v pravidelnej medikácii astmy, žiadna exacerbácia ťažkej astmy najmenej
štyri týždne pred screeningovou návštevou
4. Pacient nefajčiaci najmenej 1 rok a so spotrebou tabaku menej než 10 krabičiek za rok v predchádzajúcom období
5. Pacient s normálnou orgánovou funkciou definovanou ako:
• Absolútny počet neutrofilov (ANC) ≥2.0 x 109/L
• Hemoglobín ≥10 g/dL
• Krvné doštičky (PTL) ≥100 x 109/L
• AST/ALT ≤2.5x ULN ( horné hranice normy)
• Bilirubín ≤1.5x ULN
• Kreatinínová klírancia ≥50 mL/min (Cockcroftov a Gaultov vzorec)
• Albumín > 1 LLN ( spodnej hranice normy)
• Urea ≤1.5 x ULN
• Proteinúria < 30 mg/dL (lakmusový papierik); v prípade proteinúrie ≥30 mg/dL, 24-hodinová proteinúria< 1.5g/24 hodín
6. Pacient-muž alebo žena starší 18 rokov
7. Pacientova hmotnosť > 45 kg a s Body Mass Indexom (BMI) > 18 kg/m²
8. Pacient –muž alebo žena vo fertilnom veku (vstupujúci do štúdie po menstruačnom cykle a s negatívnym tehotenským testom) musí súhlasiť s použitím dvoch metód (jedna pre pacienta a jedna pre partnera) medicínsky akceptovateľnej antikoncepcie behom štúdie a behom 3 mesiacov po poslednej študijnej medikácii.
9. Pacient schopný a ochotný súhlasiť so študijnými procedúrami podľa protokolu
10. Pacient schopný porozumieť karte pacienta a riadiť sa na nej napísanými postupmi v prípade príznakov a symptómov vážnej neutropénie alebo vážnej kožnej toxicity behom prvých dvoch mesiacov liečby
11. Pacient schopný porozumieť, podpísať a dátovať formulár informovaného súhlasu na screeningovej návšteve pred špecifickými študijnými procedúrami

E.4

Principal exclusion criteria

1. Female patient who is pregnant or lactating
2. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
3. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
4. Patient presenting with cardiac disorders defined by at least one of the following conditions will be excluded:
a. Ischemic heart disease, defined by at least one of the following conditions:
i. Medical history of ischemic heart disease
ii. Clinical symptoms of ischemic heart disease
iii. Q wave > 3 mm on the electrocardiogram
iv. ST elevation or depression > 2 mm on the electrocardiogram
v. Negative T wave in at least 2 leads of the electrocardiogram
b. Cardiac failure, defined by at least one of the following conditions:
i. Medical history of cardiac failure defined by a previous left ventricular ejection fraction ≤ 50%
ii. Clinical symptoms of cardiac failure
iii. Current treatment for cardiac failure
iv. NT Pro-BNP ≥ 300 pg/mL or BNP ≥ 75 pg/mL and/or troponin T > 0.1 ng/mL or troponin I > 0.35 ng/mL
c. Conduction disorders or arrhythmia, defined by at least one of the following and confirmed by electrocardiogram:
i. Severe ventricular arrhythmia (frequent premature ventricular beats)
ii. Atrioventricular block at second or third level
iii. Left bundle branch block
5. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
6. Patient who had a major surgery within 2 weeks prior to screening visit
7. Patient with life expectancy < 6 months
8. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
9. Patient with any severe and/or uncontrolled medical condition
10. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
12. Patient with inadequate wash-out time at the screening visit:
Wash-out time for prohibited concomitant asthma medications:
Treatment with the following non-steroidal controllers has to be stopped about 24 h prior to screening visit: sustained-release theophylline, leukotriene antagonists, lipoxygenase inhibitors, inhaled anticholinergics, oral beta2-agonists, inhaled disodium cromoglycate, inhaled nedocromil.
Wash-out time for allowed concomitant asthma medications
• Long acting Beta agonists (12h prior to screening visit)
• Short acting agonists (6h prior to screening visit)
13. Patient treated with prohibited medications

RANDOMISATION CRITERIA (to be checked at W0):
1. Good study treatment (i.e. placebo) compliance (≥80%) during the 2-week run-in period
2. Daily mean symptom score ≥ 2 during the 2-week run in period
3. No asthma exacerbation (moderate or severe) during the 2-week run in period

1. Pacient -žena, ktorá je tehotná alebo kojacia
2. Astmatický pacient stále ešte vystavený alergénom alebo spúšťacím faktorom ovplyvňujúcim kontrolu astmy
3. Pacient s históriou akútnej infekčnej sinusitídy alebo infekciou dýchacích ciest behom 4 týždňov pred screeningovou návštevou
4. Pacient s poškodením srdca definovaným najmenej jednou z nasledujúcich podmienok bude vyradený: a. Pacient s nedávnou srdcovou históriou (do 6 mesiacov):
i. Akútny koronárny syndróm
ii. Akútne srdcové zlyhanie (triedy III alebo IV klasifikácie NYHA)
iii. Významná komorová arytmia (pretrvávajúca komorová tachykardia, komorová fibrilácia, resuscitovaná z náhlej smrti)
b. Pacient so srdcovým zlyhaním triedy III alebo IV klasifikácie NYHA
c. Pacient s ťažkou poruchou vedenia, ktorej nie je zabránené trvalým kardiostimulátorom (atrioventrikulárny blok 2 a 3, sino-atriálny blok)
d. Synkópa bez známej etiológie do 3 mesiacov
e. Nekontrolovateľná ťažká hypertenzia, podľa mienenia vyšetrovateľa, alebo symptomatická hypertenzia
5. Pacient s aktívnym pľúcnym ochorením iným než astma (napr. chronická bronchitída)
6. Pacient, který mal závažnú operáciu behom 2 týždňov pred screeningovou návštevou
7. Pacient s predpokladanou dĺžkou života < 6 mesiacov
8. Pacient s históriou primárnej malignity < 5 rokov, mimo liečenej bazocelulárnej rakoviny kože alebo cervikálneho karcinómu maternice in situ
9. Pacient s akýmkoľvek ťažkým a/alebo nekontrolovateľným zdravotným stavom
10. Pacient so známou diagnózou infekcie víru ľudskej imunodeficiencie (HIV)
11. Pacient známy zlou spoluprácou alebo históriou drogovej/alkoholovej závislosti alebo nadmernej konzumácie alkoholu, ktorá by ovplyvnila schopnosť dodržovať študijný protokol, alebo súčasné alebo predchádzajúce psychiatrické ochorenia, ktoré by mohli ovplyvniť schopnosť dodržovať študijný protokol, alebo dať informovaný súhlas
12. Pacient s nedostačujúcou vymývacou periódou vo screeningovej návšteve:
Vymývacia perióda pre zakázanú sprievodnú medikáciu astmy:
Liečba s následnými nesteroidnými kontrolórmi musí byť zastavená 24 h pred screeningovou návštevou: dlhodobo uvoľňované teofylíny, leukotrienoví antagonisti, lipoxygenázové inhibítory, inhalované anticholinergiká, orálny beta2-agonisti, inhalovaný disodium cromoglykát, inhalovaný nedocromil.
Premývacia doba pre povolenú sprievodnú medikáciu astmy:
• Dlho pôsobiaci beta2 agonisti (12h pred screeningovou návštevou)
• Krátko pôsobiaci beta2 agonisti (6h pred screeningovou návštevou)
13. Pacient liečený zakázanou medikáciou

E.5 End points

E.5.1

Primary end point(s)

Asthma exacerbation rate (severe and moderate exacerbations) at 36 weeks adjusted on the available person-time (time to end of treatment)

Počet ťažkých a stredne ťažkých exacerbácií astmy v 36 týždňoch priradených k individuálnej dobe liečby (doba do konca liečby)

E.5.1.1

Timepoint(s) of evaluation of this end point

Asthma exacerbation rate (severe and moderate exacerbations) at 36 weeks adjusted on the available person-time (time to end of treatment)

Počet ťažkých a stredne ťažkých exacerbácií astmy v 36 týždňoch priradených k individuálnej dobe liečby (doba do konca liečby)

E.5.2

Secondary end point(s)

• Dotazník kontroly astmy (ACQ) stav v 12, 20, 28 a 36 týždni
• Počet stredne ťažkých a ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Počet ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Doba do prvej exacerbácie astmy (ťažká alebo stredne ťažká)
• Percento pacientov s výskytom najmenej jednej exacerbácie astmy v 12, 20, 28 a 36 týždni
• Usilovný výdychový objem v prvej sekunde (FEV1), usilovná vitálna kapacita (FVC), prietok pri usilovnom výdychu medzi 25-75% z FVC (FEF25-75) v 12, 20, 28 a 36 týždni
• Ranný a večerný vrcholný výdychový prietok (PEFR) v 12, 20, 28 a 36 týždni
• Použitie záchrannej medikácie pre astmu v 12, 20, 28 a 36 týždni
• Hodnotenie kvality života: AQLQ stav pri každej návšteve v 12, 20, 28 a 36 týždni

E.5.2.1

Timepoint(s) of evaluation of this end point

• Asthma Control Questionnaire (ACQ) Score at 12, 20, 28 and 36 weeks
• Moderate and severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
• Severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
• Percentage of patient experiencing at least one exacerbation at 12, 20, 28 and 36 weeks
• Asthma symptom score at all time points
• Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow between 25-75% of FVC (FEF25-75) at 12, 20, 28 and 36 weeks
• Morning and evening Peak Expiratory Flow Rate (PEFR) at 12, 20, 28 and 36 weeks
• Use of rescue medication for asthma at 12, 20, 28 and 36 weeks
• Quality of Life assessment: AQLQ score at each visit at 12, 20, 28 and 36 weeks

• Dotazník kontroly astmy (ACQ) stav v 12, 20, 28 a 36 týždni
• Počet stredne ťažkých a ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Počet ťažkých exacerbácií astmy v 12, 20, 28 a 36 týždni
• Percento pacientov s výskytom najmenej jednej exacerbácie astmy v 12, 20, 28 a 36 týždni
• Usilovný výdychový objem v prvej sekunde (FEV1), usilovná vitálna kapacita (FVC), prietok pri usilovnom výdychu medzi 25-75% z FVC (FEF25-75) v 12, 20, 28 a 36 týždni
• Ranný a večerný vrcholný výdychový prietok (PEFR) v 12, 20, 28 a 36 týždni
• Použitie záchrannej medikácie pre astmu v 12, 20, 28 a 36 týždni
• Hodnotenie kvality života: AQLQ stav pri každej návšteve v 12, 20, 28 a 36 týždni

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

100

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

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

Posledná návšteva posledného pacienta vo štúdii

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
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.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	35
F.4.2	For a multinational trial
F.4.2.1	In the EEA	250
F.4.2.2	In the whole clinical trial	300

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-09-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-22

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

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Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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