Clinical Trials Register

Summary
EudraCT Number:	2012-003776-40
Sponsor's Protocol Code Number:	CL-N-CSM-AV-III/05/12
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-22
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

Germany - BfArM

A.2

EudraCT number

2012-003776-40

A.3

Full title of the trial

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N versus Custodiol

Eine prospektive, randomisierte, doppelblinde und multizentrische Phase III Studie Zum Vergleich zweier Kardioplegie-Methoden bei Aortenklappen –Operationen: Custodiol-N versus Custodiol

A.3.1

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

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N versus Custodiol

Eine prospektive, randomisierte, doppelblinde und multizentrische Phase III Studie Zum Vergleich zweier Kardioplegie-Methoden bei Aortenklappen –Operationen: Custodiol-N versus Custodiol

A.3.2

Name or abbreviated title of the trial where available

Custodiol-N-AVS

A.4.1

Sponsor's protocol code number

CL-N-CSM-AV-III/05/12

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	Dr. Franz Köhler Chemie GmbH
B.1.3.4	Country	Germany
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	Firma Dr. F. Köhler Chemie GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dr. Franz Köhler Chemie GmbH
B.5.2	Functional name of contact point	Dr. Roman Petrov
B.5.3	Address:
B.5.3.1	Street Address	Werner-Siemens-Str. 14 - 28
B.5.3.2	Town/ city	Bensheim
B.5.3.3	Post code	64625
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49625110830
B.5.5	Fax number	+4962511083146
B.5.6	E-mail	r.petrov@koehler-chemie.de

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.2.1.1.1	Trade name	Custodiol-N®
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. Franz Köhler Chemie GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Custodiol-N®
D.3.4	Pharmaceutical form	Lyophilisate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use Intracardiac use Intracoronary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	71-00-1
D.3.9.3	Other descriptive name	HISTIDINE
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	124
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3,2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,02
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	GLYCINE
D.3.9.4	EV Substance Code	SUB12000MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	56-41-7
D.3.9.3	Other descriptive name	ALANINE
D.3.9.4	EV Substance Code	SUB05290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRYPTOPHAN
D.3.9.1	CAS number	73-22-3
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	ARGININE
D.3.9.4	EV Substance Code	SUB05560MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	N-Acetylhistidine Monohydrate
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	57,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	alpha-Ketoglutaric acid
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEFEROXAMINE MESILATE
D.3.9.1	CAS number	138-14-7
D.3.9.4	EV Substance Code	SUB01571MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,0250
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LK 614
D.3.9.3	Other descriptive name	3,4-Dimethoxy-N-methylbenzhydroxam acid
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,0075
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	56-84-8
D.3.9.3	Other descriptive name	ASPARTIC ACID
D.3.9.4	EV Substance Code	SUB11721MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	WATER FOR INJECTION
D.3.9.4	EV Substance Code	SUB12398MIG
D.3.10	Strength
D.3.10.1	Concentration unit	l litre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	SODIUM HYDROXIDE SOLUTION
D.3.9.4	EV Substance Code	SUB20366
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	SACCHAROSE
D.3.9.4	EV Substance Code	SUB20801
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	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	Custodiol®
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. F. Köhler Chemie GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Custodiol®
D.3.4	Pharmaceutical form	Lyophilisate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use Intracardiac use Intracoronary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB23513
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	HISTIDINE HYDROCHLORIDE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB12023MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	18,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	71-00-1
D.3.9.3	Other descriptive name	HISTIDINE
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRYPTOPHAN
D.3.9.1	CAS number	73-22-3
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	D-MANNITOL
D.3.9.4	EV Substance Code	SUB20970
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,015
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	potassium hydrogen-2-ketoglutarat
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	WATER FOR INJECTION
D.3.9.4	EV Substance Code	SUB12398MIG
D.3.10	Strength
D.3.10.1	Concentration unit	l litre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1,0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POTASSIUM HYDROXIDE SOLUTION 50%
D.3.9.4	EV Substance Code	SUB78161
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with aortic valve disease and has to undergo aortic valve surgery +/- bypass surgery.

E.1.1.1

Medical condition in easily understood language

Patients with aortic valve disease and has to undergo aortic valve surgery +/- bypass surgery.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

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 of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, Custodiol and Custodiol-N in patients undergoing aortic valve surgery +/- bypass surgery.

E.2.2

Secondary objectives of the trial

to demonstrate superiority in surgical outcome of Custodiol-N compared with Custodiol as determined by CK-MB peak value between 4 - 24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The study population will be selected from patients of either sex who are to undergo for aortic valve surgery (with and without coronary bypass surgery).

(1) Patients >/=30 and </= 85 years of age
(2) Male or female with aortic valve disease
(3) Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
(4) Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.

E.4

Principal exclusion criteria

(1) History of recent (< 6 weeks) Q-wave myocardial infarction
(2) Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
(3) Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
(4) Pregnant or lactating patients
(5) Patients who have participated in any other investigational studies within 30 days previous to enrollment
(6) Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
(7) Patients with severe chronic obstructive lung disease (FEV1 < 50%)
(8) Previous cardiac valvular disease (clinical relevant)
(9) GFR <60 ml/min
(10) Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale
(11) Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination
(12) History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.

E.5 End points

E.5.1

Primary end point(s)

CK-MB peak value

E.5.1.1

Timepoint(s) of evaluation of this end point

from 4 to 24 hours (measurements 4, 8, 12, 16, 20, 24 hours ± 30 min) after release of the aortic cross clamp

E.5.2

Secondary end point(s)

• Catecholamine requirement on SICU within 24 hours (cumulative dose)
• CK-MB (peak) on the days 2, 3, 4 and 5 after removal of aortic cross clamp
• Cardiac Troponin T 4, 8, 12, 16, 20, 24 hours ± 30 min and on the days 2, 3, 4 and 5 after release of the aortic cross clamp
• CK-MB area under the curve between 4 and 24 hours after removal of the aortic cross-clamp
• Troponin T area under the curve between 4 and 24 hours after removal of the aortic cross-clamp
• Defibrillation
• Requirement for IABP
• Blood pressure
• Length of SICU stay
• Duration of mechanical ventilation (intubation to extubation)
• Occurrence, severity, type, and duration of cardiac arrhythmias
• Laboratory parameters
• Repeated patient transfer to SICU
• Mortality any time during post-op through Day 30
• Safety (documentation and reporting of AE and SAE)

E.5.2.1

Timepoint(s) of evaluation of this end point

see above (Point E.5.2)

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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:

170

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

190

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

500

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 who needed further treatment after study end will be treated according to current standard care.

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

2013-09-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-08

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

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