Clinical Trials Register

Summary
EudraCT Number:	2012-002944-25
Sponsor's Protocol Code Number:	EuroHyp-1
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-04-16
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

Finland - Fimea

A.2

EudraCT number

2012-002944-25

A.3

Full title of the trial

EuroHYP-1: European multicentre, randomised, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

Euro-HYP: Eurooppalainen prospektiivinen avoin satunnaistettu kliininen monikeskustutkimus (faasi III) terapeuttisen hypotermian tehosta ja turvallisuudesta aivoinfarktin hoidossa standardihoitoon verrattuna

A.3.1

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

EuroHYP-1: European phase III clinical trial at multiple trial sites and with random allocation of patients to treatment groups. The trial compares whole body cooling plus best medical treatment to best medical treatment alone in patients with acute stroke.

EuroHYP: Eurooppalainen faasi III kliininen tutkimus, jossa on useita keskuksia ja tutkittavat satunnaistetaan kahteen hoitoryhmään. Tutkimuksessa verrataan aivohalvauspotilailla koko kehon viilennyshoitoa ja lääkehoitoa pelkkään lääkehoitoon.

A.3.2

Name or abbreviated title of the trial where available

EuroHYP-1

A.4.1

Sponsor's protocol code number

EuroHyp-1

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01833312

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 Hospital Erlangen
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	European Comission
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Hospital Erlangen
B.5.2	Functional name of contact point	University Hospital Erlangen
B.5.3	Address:
B.5.3.1	Street Address	Schwabachanlage 6
B.5.3.2	Town/ city	Erlangen
B.5.3.3	Post code	91054
B.5.3.4	Country	Germany
B.5.6	E-mail	stefan.schwab@uk-erlangen.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	Yes
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.3.4	Pharmaceutical form	Solution for injection
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	PETHIDINE HYDROCHLORIDE
D.3.9.1	CAS number	50-13-5
D.3.9.3	Other descriptive name	PETHIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03726MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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.2.1.2	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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BUSPIRONE HYDROCHLORIDE
D.3.9.1	CAS number	33386-08-2
D.3.9.3	Other descriptive name	BUSPIRONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00906MIG
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	30
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	Ondansetrone
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Ondansetron
D.3.2	Product code	A04AA01
D.3.4	Pharmaceutical form	Injection
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.3.9.2	Current sponsor code	A04AA01
D.3.9.3	Other descriptive name	ONDANSETRON HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03517MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	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: 4
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	Granisetron Fresenius Kabi
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Granisetron Fresenius Kabi
D.3.2	Product code	A04AA02
D.3.4	Pharmaceutical form	Injection
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	GRANISETRON HYDROCHLORIDE
D.3.9.1	CAS number	107007-99-8
D.3.9.2	Current sponsor code	A04AA02
D.3.9.4	EV Substance Code	SUB02405MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

Acute ischaemic stroke

Akuutti aivoinfarkti

E.1.1.1

Medical condition in easily understood language

Acute ischaemic stroke

Akuutti aivoinfarkti

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061256
E.1.2	Term	Ischaemic stroke
E.1.2	System Organ Class	10029205 - Nervous system 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

To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.

Selvittää parantaako 6 tunnin kuluessa aivoinfarktin oireista aloitettu ja 24 tuntia kestävä kehon lämpötilan alentaminen 34-35 C asteeseen aivoinfarktipotilaiden toipumista 3 kk kuluttua sairastumisesta.

E.2.2

Secondary objectives of the trial

 To assess the effect of systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, in patients with acute ischaemic stroke on
• mortality at 3 months.
• neurological outcome at 3 months.
• quality of life at 3 months.
• cerebral infarct size at 48±24 hours.
 To determine the safety and tolerability of systemic cooling in patients with acute ischaemic stroke.

Selvittää hypotermiahoidon vaikutus aivoinfarktipotilaan
-kuolleisuuteen 3 kk kuluessa
-neurologiseen toipumiseen 3 kk kuluttua
-elämänlaatuun 3 kk kuluttua
-aivoinfarktin kokooon 1-3 vrk hoidon jälkeen
Selvittää hypotermiahoidon turvallisuus ja siedettävyys akuutissa aivoinfarktissa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The trial population consists of patients of both sexes, aged ≥18 years, with acute ischaemic stroke and a score on the NIHSS of 6 up to and including 18 at screening [Assessment 1, within 90 minutes before the start of the treatment phase TP].
 Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries.
 Estimated body weight of 50kg up to and including 120kg.
 Possibility to start therapeutic hypothermia within 6 hours after onset of stroke.
 Possibility to start therapeutic hypothermia within 90 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site.
 Possibility to start therapeutic hypothermia within 90 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site.
 mRS score ≤2 prior to onset of stroke.
 GCS motor response subscale score ≥5.

18 vuotta täyttäneitä potilaita, kumpaakin sukupuolta, joilla diagnosoitu akuutti aivoinfarkti (NIHSS 6-18)
-Tietoon perustuva suostumus on saatu tutkittavalta tai hänen läheiseltään.
-Tutkittavan paino 50-120 kg
-tutkimushoito voidaan aloittaa 6 tunnin kuluessa aivoinfarktin alkuoireista.
-Tukimushoito on mahdollista aloittaa 90 min kuluessa mahdollisen aivoinfarktin liuotushoidon alusta.
-Tutkimushoito on mahdollista aloittaa 90 min kuluessa sairaalan sapumisesta niillä potilailla jotka eivät saa liuotushoitoa
-mRS pistemäärä enintään 2 pistettä

E.4

Principal exclusion criteria

1. Use of monoaminoxidase inhibitors in the 14 days prior to screening.
2. Current use of medication interacting with pethidine or buspirone.
3. Acute alcohol intoxication.
4. Opioid addiction.
5. Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential.
6. Known hypersensitivity to the IMPs or any of their formulation ingredients.
7. Patient who is imprisoned or is lawfully kept in an institution.
8. Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor.
9. Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial.
10. Prior participation in this trial.
11. Any acutely life-threatening conditions other than acute ischaemic stroke.
12. Rapidly resolving stroke symptoms.
13. Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke.
14. Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis.
15. SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration.
16. Other severe respiratory disorder.
17. Bradycardia (<40 bpm).
18. Severe cardiac failure, defined as NYHA classification ≥III.
19. Myocardial infarction or angina pectoris in the 3 months prior to screening.
20. Vasospastic disorders.
21. Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia).
22. Known platelet count <100,000/mm3.
23. Known INR >1.7.
24. Skin damage at the sites intended to be used for cooling.
25. Clinical diagnosis of sepsis.
26. Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN).
27. Known renal impairment (serum creatinine >2mg/100ml).
28. Addison’s disease.
29. Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia.
30. Any condition that is thought to reduce the compliance to cooperate with the trial procedures .

ks. englanninkieliset

E.5 End points

E.5.1

Primary end point(s)

Score on the mRS.

mRS pistemäärä.

E.5.1.1

Timepoint(s) of evaluation of this end point

At outcome assessment [A7, Day 90±14 days].

Päivä 90±14 päivää

E.5.2

Secondary end point(s)

 Death or dependency, defined as a score on the mRS >2.
 Death.
 Score on NIHSS.
 Brain infarct size.
 WHODAS 2.0 score.
 EQ-5D-5L score.

 Kuolema tai ei-omatoiminen toipuminen mRS >2.
 Kuolema.
 NIHSS pistemäärä.
 Aivoinfarktin koko
 WHODAS 2.0-pisteet.
 EQ-5D-5L-pisteet.

E.5.2.1

Timepoint(s) of evaluation of this end point

 Death or dependency, defined as a score on the mRS >2 at outcome assessment [A7, Day 91±14 days].
 Death at outcome assessment [A7, Day 91±14 days].
 Score on NIHSS at outcome assessment [A7, Day 91±14 days].
 Brain infarct size at imaging assessment [A4, Hour 48±24 hours].
 WHODAS 2.0 score at outcome assessment [A7, Day 91±14 days].
 EQ-5D-5L score at outcome assessment [A7, Day 91±14 days].

ks. englanninkielinen

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Standardihoito

Best medical treatment.

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

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

LVLS.

viimeisen potilaan viimeinen käynti

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

If patient is unable to reach a balaced view of the potential risk and benefits of participation his/her legally acceptable representative can give a consent.

Jos tutkittava ei voi antaa tietoista suostumusta, pyydetään suostumus hänen omaiseltaan.

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

1500

F.4.2.2

In the whole clinical trial

1500

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)

Standard therapy.

Standardihoito

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	EuroHYP - European Stroke Research Network for Hypothermia
G.4.3.4	Network Country	Belgium

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-03-02

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