Clinical Trials Register

Summary
EudraCT Number:	2009-009916-33
Sponsor's Protocol Code Number:	00332/AMLSG14-09
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:	2010-10-11
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

2009-009916-33

A.3

Full title of the trial

Prospective randomized multicenter phase II trial of low-dose decitabine (DAC) administered alone or in combination with the histone deacetylase inhibitor valproic acid (VPA) and all-trans retinoic acid (ATRA) in patients > 60 years with acute myeloid leukemia who are ineligible for induction chemotherapy

Prospektive, randomisierte, multizentrische Phase II Studie mit niedrig-dosiertem Decitabine (DAC) alleine oder in Kombination mit dem Histon- Deacetylase Inhibitor Valproat (VPA) und All-Transretinsäure (ATRA) bei Patienten über 60 Jahre mit akuter myeloischer Leukämie, bei denen eine Standard-Induktions-Chemotherapie nicht geeignet ist

A.3.1

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

Clinical trial of low-dose decitabine (DAC) administered alone or in combination with the valproic acid (VPA) and all-trans retinoic acid (ATRA) in patients > 60 years with acute myeloid leukemia who are ineligible for standard chemotherapy

Klinische Studie mit niedrig-dosiertem Decitabine (DAC) alleine oder in Kombination mit dem Valproat (VPA) und All-Transretinsäure (ATRA) bei Patienten über 60 Jahre mit akuter myeloischer Leukämie, bei denen eine Standard-Chemotherapie nicht geeignet ist

A.3.2

Name or abbreviated title of the trial where available

DECIDER Trial

DECIDER

A.4.1

Sponsor's protocol code number

00332/AMLSG14-09

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	University Medical Center Freiburg
B.1.3.4	Country	Germany
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	federal ministry of education and research
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
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	Yes
D.2.5.1	Orphan drug designation number	EMEA/OD/059/02
D.3 Description of the IMP
D.3.1	Product name	decitabine
D.3.2	Product code	Dacogen
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DECITABINE
D.3.9.1	CAS number	2353335
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	50
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	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	Valproinsäure-ratiopharm chrono 500
D.2.1.1.2	Name of the Marketing Authorisation holder	Ratiopharm
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	Valproic acid
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Enteral use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VALPROIC ACID
D.3.9.1	CAS number	99661
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	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	No
D.IMP: 3
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	Vesanoid
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Pharma AG
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	All-Trans Retinoic Acid
D.3.2	Product code	ATRA
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Enteral use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRETINOIN
D.3.9.1	CAS number	302794
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	10
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 older than 60 years with acute myeloid leukemia according to WHO (≥ 20 % blasts in the peripheral blood (pB) or bone marrow (BM)) not qualifying for, or not consenting to, standard remission-induction chemotherapy or immediate allografting

Patienten älter als 60 Jahre mit akuter myeloischer Leukämie, entsprechend WHO (≥ 20 % Blasten im Knochenmark oder im peripheren Blut), welche nicht geeignet für eine Standard-Induktions-Chemotherapie oder unmittelbare Allotransplantation sind oder diesen nicht zustimmen.

E.1.1.1

Medical condition in easily understood language

Patients older than 60 years with acute myeloid leukemia not qualifying for, or not consenting to, standard remission-induction chemotherapy or immediate allografting

Patienten älter als 60 Jahre mit akuter myeloischer Leukämie, welche nicht geeignet für eine Standard-Induktions-Chemotherapie oder unmittelbare Allotransplantation sind oder diesen nicht zustimmen.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10000886
E.1.2	Term	Acute myeloid leukemia
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Main objective is to answer the research question of whether a combination of low-dose DAC combined with the histone deacetylase inhibitor VPA and / or ATRA is able to increase the objective response rate to low-dose-DAC alone in AML of the elderly. The hypothesis that the combination is more active than single-agent DAC is based on a plethora of in vitro data indicating a synergism between both epigenetic modifiers (Cameron et al., 1999)

E.2.2

Secondary objectives of the trial

- Overall best response rate (CR, PR and antileukemic effect (ALE))
- Progression-free survival (PFS)
- Overall survival (OS)
- Quality of life (QOL)
- Number of nights in hospital
- Safety

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Translational studies (METHYLATION AND EXPRESSION PROFILING)
1. investigate whether a distinct gene methylation and mRNA expression profile correlates with clinical parameters
2. seek to predict treatment response by global DNA methylation changes
3. study the in vivo molecular changes induced by a DNA methylating agent and 4 different drug treatments

E.3

Principal inclusion criteria

1. Written informed consent obtained according to international guidelines and local law;
2. Male or female patients aged > 60 years without upper age limit;
3. Patients with primary or secondary AML according to WHO (≥ 20% blasts in the peripheral blood (pB) or bone marrow (BM)) who are not expected to benefit from standard remission-induction chemotherapy;
4. Patients with < 30 000 leukocytes/µl;
5. Performance status ECOG 0, 1, 2;
6. Creatinine < 2.0 mg/dl (unless leukemia-related);
7. Ability to understand the nature of the study and the study related procedures and to comply with them.

1. Vorliegen einer schriftlichen Patienten-Einwilligungserklärung
2. Männer und Frauen > 60 Jahre ohne obere Altersgrenze
3. Patienten mit de novo oder sekundärer akuter myeloischer Leukämie (AML) entsprechend WHO (>= 20% Blasten im Knochenmark oder im peripheren Blut) bei welchen kein Vorteil durch eine Standard -Induktions-Chemotherapie zu erwarten ist
4. Patienten mit < 30 000 Leukozyten/µl;
5. Performance status ECOG 0, 1, 2;
6. Kreatinin < 2,0 mg/dl) es sei denn, im Zusammenhang mit Leukämie
7. Willens und in der Lage, alle Anforderungen des Prüfplans zu erfüllen

E.4

Principal exclusion criteria

1. AML of FAB subtype M3;
2. Previous remission-induction chemotherapy for MDS or AML, previous allografting;
3. Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA;
4. "Low-dose" chemotherapy (e.g. hydroxyurea, cytosine arabinoside (Ara-C), melphalan, clofarabine etc.) within 4 weeks prior to DAC treatment, except for cytoreduction of leukocytosis ≥ 30 000/µl with hydroxyurea or Ara-C as proscribed by the study protocol (section 7.3 and 7.4); the patient must have recovered from all clinically relevant reversible non-hematologic toxicities;
5. Treatment with tyrosine kinase inhibitors, immunomodulating agents (IMIDS) or other investigational AML treatment within the last 4 weeks or in a time period of drug half-life x 5 (whatever is shorter) before the first administration of DAC;
6. Treatment with cytokines within previous 4 weeks;
7. Concomitant therapy which is considered relevant for the evaluation of efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy);
8. Other malignancy requiring treatment (previous chemotherapy for other malignancies is not an exclusion criteria);
9. Cardiac insufficiency NYHA IV;
10. Insufficient hepatic function (bilirubin, AST or ALT > = 2.5 x Upper Limit of Normal (ULN)) (unless leukemia-related);
11. Fatal hepatic function disorder during treatment with valproic acid in siblings;
12. Hepatic porphyria;
13. Manifest serious pancreatic function disorder;
14. Plasmatic coagulation disorder not related to AML;
15. Known active hepatitis B or C;
16. Known HIV infection;
17. Other uncontrolled active infections;
18. Known allergy against soy beans or peanuts;
19. Psychiatric disorder that interferes with treatment;
20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study;
21. Known hypersensitivity to, or intolerance of, one of the trial drugs, another retinoid or the excipients of the trial drugs;
22. Concomitant use of any other investigational drug or participation in a clinical trial within the last thirty days before the start of this study; simultaneous participation in registry and diagnostic trials is allowed;
23. Female patients who are pregnant or breast feeding;
24. Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 5.3);
25. Known or persistent abuse of medication, drugs or alcohol.

1. AML klassifiziert nach FAB Subtyp M3;
2. Vorangegangene Induktions-Chemotherapie für MDS oder AML, vorangegangene Allotransplantation;
3. Vorangegangene Behandlung mit DAC, 5-azacytidine, VPA oder einem anderen HDAC Inhibitor, oder ATRA;
4. Niedrigdosierte Chemotherapie wie Hydroxyurea, AraC, Melphalan, Clofarabine (mind. 4 Wochen Behandlungsstop vor der Decitabine Behandlung). Ausnahme: Zytoreduktion mit Hydroxyurea und AraC, laut Studienprotokoll, bei Leuko-zytose ≥ 30 000/µl (Abschnitt 7.3 und 7.4); der Patient muss sich von allen reversiblen nicht hämatologischen Toxizitäten wieder erholt haben;
5. Behandlung mit Tyrosinkinase-Inhibitoren, immune modulating agents (IMIDS) oder anderer Behandlung der AML mit Prüfsubstanzen in den vorausgegangen 4 Wochen bzw. im Zeitraum von fünf Halbwertszeiten (wenn dieser entsprechend kürzer ist) vor der ersten DAC-Gabe;
6. Behandlung mit Zytokinen in den vorausgegangen 4 Wochen;
7. Begleittherapie, die relevant für die Beurteilung der Wirksamkeit oder Sicherheit der Studienmedikation ist (d.h. andere Chemo- oder Immuntherapie );
8. Andere maligne Erkrankungen die Behandlung erfordern (vorangegangene Chemotherapie für andere maligne Erkrankungen sind kein Ausschlusskriterium);
9. Herzinsuffizienz NYHA IV;
10. Unzureichende Leberfunktion (Billirubin, AST oder ALT > = 2,5x über Normwert (ULN)) sofern nicht mit Leukämie in Verbindung stehend;
11. Fatal Leberfunktion Störungen während der Behandlung mit Valproinsäure bei Geschwistern;
12. Hepatische Porphyrie;
13. Manifest schwere Erkrankung des Pankreas-Funktion;
14. Plasmatische Gerinnungsstörungen, die unabhängig von der AML vorliegen;
15. Bekannte aktive Hepatitis B oder C;
16. Bekannte HIV Infektion;
17. Andere unkontrollierte aktive Infektionen;
18. Bekannte Allergien gegen Soya und Erdnüsse;
19. Psychiatrische Erkrankungen, die eine Behandlung nicht ermöglichen würden;
20. Patient ohne Rechts- und Geschäftsfähigkeit, der nicht in der Lage ist, die Wesen, Bedeutung und Folgen der Studie zu verstehen;
21. Bekannte Überempfindlichkeit oder Unverträglichkeit gegen eines der Studienmedikamente oder deren Hilfsstoffe;
22. Behandlung mit anderen Prüfpräparaten oder Teilnahme an anderen klinischen Prüfungen innerhalb der letzten 30 Tage vor Beginn der Studie; eine zeitgleiche Teilnahme an registrierenden und diagnostischen Studien ist möglich;
23. Schwangere oder stillende Frauen;
24. Zeugungsfähige Männer oder gebärfähige Frauen, die nicht Willens sind, Mittel zur Empfängnisverhütung anzuwenden (siehe Abschnitt 5.3)
25. Bekannter oder anhaltender Missbrauch von Medikamenten, Drogen oder Alkohol.

E.5 End points

E.5.1

Primary end point(s)

Objective best response rate (complete remission (CR) and partial remission (PR))

Beste objektive Responserate (Vollremission (CR), Teilremission (PR))

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months after randomization of the last patient

12 Monate nach der Randomisierung des letzten Patienten

E.5.2

Secondary end point(s)

Overall best response rate (CR, PR and antileukemic effect (ALE)), progression-free survival (PFS), overall survival (OS), quality of life (QOL), number of nights in hospital, safety

Gesamt-Responserate (Vollremission (CR), Teilremission (PR), antileukämischer Effekt (ALE)), Progressionsfreies Überleben (PFS), Gesamtüberleben, Lebensqualität, Anzahl der Übernachtungen im Krankenhaus, Sicherheit

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months after randomization of the last patient

12 Monate nach der Randomisierung des letzten Patienten

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

2x2 factorial design, observer blind

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

Decitabine alone

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

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

see clinical trial protocol section 10

siehe Prüfplan Kapitel 10

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.1.1.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

200

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)

After the end of study, control examinations take place according to the present standard of care of the participating clinic. Therapy can be continued if the treating physician judges that the patient is benefiting from continued treatment with study drug according to the protocol.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-05-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-05-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-07-13

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