Clinical Trials Register

Summary
EudraCT Number:	2014-003066-24
Sponsor's Protocol Code Number:	MW2012-01-01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-04-02
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

Austria - BASG

A.2

EudraCT number

2014-003066-24

A.3

Full title of the trial

A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

Eine multizentrische, multinationale, randomisierte, kontrollierte unverblindete Studie bei Kindern mit thermalen Verbrennungen zur Beurteilung der Wirksamkeit und Sicherheit von NexoBrid im Vergleich zur Standardbehandlung (SOC; standard of care)

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

MW2012-01-01

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/006/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MediWound Ltd.
B.1.3.4	Country	Israel
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	MediWound Ltd.
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GCP-Service International Ltd. & Co. KG
B.5.2	Functional name of contact point	Sergej Graf
B.5.3	Address:
B.5.3.1	Street Address	Anne-Conway-Str. 2
B.5.3.2	Town/ city	Bremen
B.5.3.3	Post code	28359
B.5.3.4	Country	Germany
B.5.4	Telephone number	004942189 67 66 35
B.5.5	Fax number	004942143 48 659
B.5.6	E-mail	sgraf@gcp-service.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	Yes
D.2.1.1.1	Trade name	NexoBrid
D.2.1.1.2	Name of the Marketing Authorisation holder	MediWound Germany GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/02/107
D.3 Description of the IMP
D.3.1	Product name	NexoBrid
D.3.4	Pharmaceutical form	Powder and gel for gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	concentrate of proteolytic enzymes enriched in bromelain
D.3.9.3	Other descriptive name	CONCENTRATE OF PROTEOLYTIC ENZYMES ENRICHED IN BROMELAIN
D.3.9.4	EV Substance Code	SUB91744
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	Yes
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	mixture of enzymes (Bromelain) extracted from pineapple stem
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	NexoBrid
D.2.1.1.2	Name of the Marketing Authorisation holder	MediWound Germany GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/02/107
D.3 Description of the IMP
D.3.1	Product name	NexoBrid
D.3.4	Pharmaceutical form	Powder and gel for gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	concentrate of proteolytic enzymes enriched in bromelain
D.3.9.3	Other descriptive name	CONCENTRATE OF PROTEOLYTIC ENZYMES ENRICHED IN BROMELAIN
D.3.9.4	EV Substance Code	SUB91744
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
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	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	Yes
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	mixture of enzymes (Bromelain) extracted from pineapple stem

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

The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

Das Studienziel ist die Beurteilung der Sicherheit und des klinischen Nutzens von NexoBrid bei hospitalisierten Kindern und Jugendlichen (0-18 Jahre) mit tiefen (Grad IIb) und sehr tiefen (Grad III) Verbrennungen von 1-30 % der TBSA (total body surcface area; totale Körperoberfläche) und Vergleich von NexoBrid mit der Standardbehandlung (SOC).

E.1.1.1

Medical condition in easily understood language

Dead tissue of a burn wound has to be removed to promote healing of the wound.

Totes Gewebe einer Verbrennungswunde muss entfernt werden, um die Wundheilung zu erziehlen.

E.1.1.2

Therapeutic area

Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	HLT
E.1.2	Classification code	10043418
E.1.2	Term	Thermal burns
E.1.2	System Organ Class	100000004863

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 main objective of the trial is:
-To demonstrate enzymatic eschar removal efficacy of NexoBrid by providing earlier, complete eschar removal
-To demonstrate enzymatic eschar removal efficacy of NexoBrid by reducing patients’ surgical burden and resulting in non inferior final outcomes of cosmesis and function as compared to SOC.
-To assess the safety of NexoBrid compared to SOC.

E.2.2

Secondary objectives of the trial

The following secondary objectives are assessed compared between SOC and NexoBrid:
1.Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This Endpoint (EP) supplements the primary EP by further assessing NexoBrid’s impact on the reduction in surgical needs.
2.Incidence of autograft performed in deep partial thickness wounds
3.Percent area of deep partial thickness wounds autografted
4.Incidence of wound closure
5.Time to reach complete wound closure assessed in days, starting from Randomization date.
6.Cosmesis assessment using MVSS
7.Long term Quality of Life will be measured using EQ5D at wk 12 and mths 6, 12, 18 and 24 following the confirmatory wound closure visit.
8.Long term functionality evaluation of the extremities (using the ‘Lower Extremity Functional Scale’ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at wk 12 and mths 6, 12, 18 and 24 following the confirmatory wound closure visit.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria- Patient level
1. Stage 1: Males and females between 4 years to 18 years of age,
Stage 2 (upon DSMB review): Males and females between 1 year to 18 years of age.
Stage 3 (upon DSMB review): Males and females between 0 years to 18 years of age.
2. Thermal burns caused by fire/flame, scalds or contact.
3. Patient total burns area ≥ 1% DPT and / or FT,
4. Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
5. Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.

Inclusion Criteria - Wound level
At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:
1. Wound that is ≥ 1% TBSA (DPT and/or FT) (not including face, perineal or genital),
2. Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
3. Wound that is intended for surgical eschar removal,
4. Wound’s blisters can be unroofed, as judged by the investigator.

Einschlusskriterien – Patienten-Ebene
1. Stufe I: Mädchen und Jungen im Alter von 4–18 Jahren.
Stufe II (nach DSMB-Prüfung): Mädchen und Jungen im Alter von 1-18 Jahren.
Stufe III (nach DSMB-Prüfung): Mädchen und Jungen im Alter von 0-18 Jahren.
2. Verbrennungen durch Feuer/Flammen, Verbrühungen oder Kontaktverbrennungen.
3. Die gesamte Verbrennungsfläche des Patienten mit ≥ 1 % des Grades IIb und/oder III.
4. Die gesamte Verbrennungsfläche des Patienten sollte ≤ 30 % der TBSA sein; Grad I-IIa, Grad IIb und/oder Grad III.
5. Eine unterzeichnete Einwilligungserklärung des gesetzlichen Vormunds kann innerhalb von 84 Stunden nach der Brandverletzung eingeholt werden.

Einschlusskriterien – Wund-Ebene
Mindestens eine Wunde (eine durchgängige Verbrennungsfläche, die in einer Behandlungssitzung behandelbar ist; kann sich über mehrere anatomische Bereiche erstrecken) des Patienten sollte alle der folgenden Kriterien erfüllen:
1. Die Wunde ist ≥ 1 % der TBSA (Grad IIb und/oder III) (Gesicht, Perineal- und Genitalbereich ausgeschlossen),
2. Die Wunde besteht aus Verbrennungen des Grades IIb und/oder III. Bereiche mit oberflächlichen Verbrennungen des Grades I und IIa können in den Wundbereich eingeschlossen werden, wenn sie sich von den tieferen Bereichen nicht abgrenzen lassen (z. B. umrandet von oder vermischt mit Verbrennungen des Grades IIb) und sonst die Behandlung der tieferen Bereiche stören würden.
3. Wunde mit Indikation für eine operative Schorfentfernung.
4. Brandblasen können nach Ansicht des Prüfarztes geöffnet werden.

E.4

Principal exclusion criteria

Exclusion Criteria
1. Patients weighing less than 3kg,
2. Patients who are unable to follow study procedures and follow up period,
3. Patients with electrical or chemical burns,
4. Patient with a continuous burn area above 15% TBSA,
5. Patients with no DPT and/or FT burn area (only SPT wounds),
6. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference),
The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
8. Patients with diagnosed infections as described in Section 13.2.6 of study protocol,
9. Diagnosis of smoke inhalation injury
10. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of >12h SSD treatment),
11. Patients with pre-enrolment escharotomy,
12. Pregnant women (positive pregnancy test) or nursing mothers,
13. Poorly controlled diabetes mellitus (HbA1c>9%),
14. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, uncontrolled asthma,
15. Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
16. Any known conditions that would preclude safe participation in the study or add further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
17. ASA greater than 2 (see Appendix 13 in study protocol)
18. Chronic systemic steroid intake,
19. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
20. Current (within 12 months prior to screening) suicide attempt,
21. Enrollment in any investigational drug trial within 4 weeksprior to screening,
22. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse2,
23. Prisoners and incarcerated
24. Patients who might depend on the clinical study site or investigator.
25. Patient expresses objection to participate in the study.
26. Patients with other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s)
27. General condition of patient would contraindicate surgery

Ausschlusskriterien
1. Patienten, die weniger als 3kg wiegen
2. Patienten, die nicht in der Lage sind, an den Studienverfahren und der Nachbeobachtungsphase teilzunehmen.
3. Patienten mit elektrischen oder chemischen Verbrennungen.
4. Patienten mit einer durchgängigen Verbrennungsfläche von mehr als 15 % TBSA.
5. Patienten mit keinen Verbrennungen des Grades IIb und/oder III (nur Grad I-IIa Wunden).
6. Patienten mit zirkulären vorderen/hinteren Rumpfverbrennungen durch Feuer/Flammen von > 15 % TBSA (zirkulär ist definiert als ≥ 80 % des Rumpfumfangs).
7. Wundbehandlung vor der Rekrutierung mit a) Flammacerium, b) Silbernitrat (AgNO3).
8. Patienten mit diagnostizierten Infektionen, die in Abschnitt 13.2.6 des Prüfplans beschrieben sind.
9. Diagnose von Rauchinhalationsschäden.
10. Patienten mit Wunden, die bereits vor der Rekrutierung bestanden und mit Schorf, der stark mit Jod durchtränkt ist, oder mit Pseudoschorf (z. B. Pseudoschorf durch die Behandlung mit SSD von > 12 Std.) bedeckt sind.
11. Patienten, bei denen vor der Rekrutierung eine Escharotomie durchgeführt wurde.
12. Schwangere (positiver Schwangerschaftstest) oder stillende Frauen.
13. Schlecht eingestellter Diabetes mellitus (HbA1c> 9 %).
14. Bekannte kardiopulmonale Erkrankung, sauerstoffpflichtige Lungenerkrankungen, Bronchopneumonie, unkontrolliertes Asthma.
15. Bekannte Erkrankung, die die Durchblutung behindert (periphere Gefäßerkrankung, Ödem, Lymphödem, Operation der regionalen Lymphknoten, Adipositas).
16. Jegliche bekannte Erkrankung, die eine sichere Teilnahme an der Studie gefährden würde oder das Risiko des ursprünglichen akuten Verbrennungstraumas zusätzlich erhöhen würde (wie z. B. immunkompromittierende Erkrankungen, lebensbedrohliches Trauma, vorbestehende schwere Blutgerinnungsstörung, Lungen-/Herz-Kreislauferkrankungen, Leber- oder neoplastische Erkrankungen).
17. ASA-Klassifikation höher als 2 (siehe Anhang 13 im Prüfplan).
18. Langzeitbehandlung mit systemischen Steroiden.
19. Bekannte Allergie und/oder Überempfindlichkeit gegen Ananas, Papaya, Bromelain oder Papain.
20. Aktueller Suizidversuch (innerhalb von 12 Monaten vor dem Screening).
21. Aufnahme in eine experimentelle Arzneimittelstudie innerhalb von 4 Wochen vor dem Screening.
22. Aktueller (innerhalb von 12 Monaten vor dem Screening) Alkohol- (täglich > 3 Einheiten bei Männern und > 2 Einheiten bei Frauen) oder Drogenabusus .
23. Häftlinge und Gefangene.
24. Patienten, die möglicherweise in einem Abhängigkeitsverhältnis mit dem Prüfzentrum oder Prüfarzt stehen.
25. Patienten, die Einwände gegen die Teilnahme an der Studie äußern.
26. Patienten mit anderen schwerwiegenden kutanen Traumata an der gleichen Stelle wie die Verbrennungen (z.B. stumpfe Abschürfungen, Avulsion oder tiefe Abrasion) oder vorherige Verbrennung(en) an derselben Behandlungsstelle.
27. Der Allgemeinzustand des Patienten würde die Operation kontraindizieren.

E.5 End points

E.5.1

Primary end point(s)

1. Earlier eschar removal (in days): Demonstrate superiority over SOC for eschar removal as measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date.
2. Reduction in surgical needs: Demonstrate superiority over SOC in reduction in surgical need for excisional eschar removal as measured by an analysis of % wound area surgically excised for eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).
3. Cosmesis and Function: Demonstrate non-inferiority to SOC in quality of scars of burns (using POSAS) treated with NexoBrid, measured at 24 months from wound closure.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Start of randomization
2. End of eschar removal
3. 24 months from wound closure.
4. Interim Analysis when all patients reach 12 months FU

E.5.2

Secondary end point(s)

1. Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This endpoint supplements the primary EP by further assessing NexoBrid’s impact on the reduction in surgical needs.
2. Incidence of autograft performed in deep partial thickness wounds only
3. % area of deep partial thickness wounds autografted
4. Incidence of wound closure
5. Time to reach complete wound closure assessed in days, starting from Randomization date
6. Cosmesis assessment using MVSS at 12 weeks and months, 6, 12, 18 and 24 following the confirmatory wound closure visit.
7. Long term Quality of Life will be measured using EQ5D at 12 weeks and months 6, 12, 18 and 24 following to the confirmatory wound closure visit.
8. Long term functionality evaluation of the extremities (using the ‘Lower Extremity Functional Scale’ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at 12 weeks and months 6, 12, 18 and 24 months following to the confirmatory wound closure visit.

E.5.2.1

Timepoint(s) of evaluation of this end point

-time until complete eschar removal has been achieved.
-end of the topical agent soaking period.
-Time to reach complete wound closure assessed in days, starting from Randomization date.
-3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

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

Yes

E.8.1.7.1

Other trial design description

scar evaluation is blinded

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Comparator arm is Standard of care

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

Austria

Belgium

Bulgaria

Czech Republic

France

Germany

Israel

Italy

Netherlands

Romania

Slovakia

Spain

Sweden

United Kingdom

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:

160

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

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)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception 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 2015-04-02.

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Both parents/legal guardians are asked to consent on child participation. Children at the age of 9 to 18 get their own additional informed consent form. If minor goes to site with one parent the other parent signature can be obtained later.

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

150

F.4.2.2

In the whole clinical trial

160

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)

Patients are treated according to standard of care after end of participation in the trial.

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

2015-05-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-23

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
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