Clinical Trials Register

Summary
EudraCT Number:	2017-003221-15
Sponsor's Protocol Code Number:	Uni-Koeln-3128
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-10-11
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2017-003221-15

A.3

Full title of the trial

PROSPEKTIV RANDOMISIERTE, MULTIZENTRISCHE STUDIE ZUM
VERGLEICH DER EINER RADIKALEN HYSTEREKTOMIE NACH
NEOADJUVANTER CHEMOTHERAPIE VERSUS EINER PRIMÄREN
RADIOCHEMOTHERAPIE BEI PATIENTINNEN MIT EINEM
ZERVIXKARZINOM
DER FIGO- STADIEN IB2 UND IIB

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

NACOPRAD-Studie

A.4.1

Sponsor's protocol code number

Uni-Koeln-3128

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	Universität zu Köln
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	Deutsche Krebshilfe
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	ZKS Tübingen
B.5.2	Functional name of contact point	Projektmanagement, Dr. Walker
B.5.3	Address:
B.5.3.1	Street Address	Frondsbergstrasse 23
B.5.3.2	Town/ city	Tübingen
B.5.3.3	Post code	72070
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49707185635
B.5.5	Fax number	+49707125080
B.5.6	E-mail	zks-pm@med.uni-tuebingen.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.3.1	Product name	CARBOPLATIN
D.3.4	Pharmaceutical form
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	Carboplatin
D.3.9.3	Other descriptive name	CARBOPLATIN
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	400
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.3.1	Product name	Paclitaxel
D.3.4	Pharmaceutical form
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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	80 to 175
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.2.1.2	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	Cisplatin
D.3.4	Pharmaceutical form
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	CISPLATIN
D.3.9.3	Other descriptive name	CISPLATIN
D.3.9.4	EV Substance Code	SUB07483MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
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.2.1.2	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	Ifosfamid
D.3.4	Pharmaceutical form
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	IFOSFAMIDE
D.3.9.1	CAS number	3778-73-2
D.3.9.4	EV Substance Code	SUB08125MIG
D.3.10	Strength
D.3.10.1	Concentration unit	gm/m2 gram(s)/square meter
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	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

Patientinnen mit einem histologisch gesicherten Plattenepithel-,
Adeno- oder adenosquamösen Zervixkarzinom FIGO Stadium
IB2 oder IIB

E.1.1.1

Medical condition in easily understood language

Patientinnen mit einem histologisch gesicherten Plattenepithel-,
Adeno- oder adenosquamösen Zervixkarzinom FIGO Stadium
IB2 oder IIB

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10008242
E.1.2	Term	Cervical carcinoma stage IB
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10008245
E.1.2	Term	Cervical carcinoma stage IIB
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

Überlegenheit bzgl. Wirksamkeit (Disease Free Survival, DFS)
der Therapie eines der beiden Arme:
Radikale Hysterektomie nach NACT mit Carboplatin, Paclitaxel
(TP) bzw. Cisplatin, Paclitaxel, Ifosfamid (TIP) versus primäre
Radiochemotherapie mit Cisplatin bei Patientinnen mit einem
Zervixkarzinom der FIGO Stadien IB2 und IIB.
Stratifiziert wird nach Zentren und FIGO-Stadium. Jedes
Zentrum muss sich entweder für TP oder TIP entscheiden.

E.2.2

Secondary objectives of the trial

Overall Survival (OS), Lebensqualität, Sexualität, Toxizität,
Morbidität.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patientin über 18 Jahre.
• Karnofsky-Index ≥70.
• durch Biopsie gesichertes Plattenepithel-, Adeno- oder
adenosquamöses Zervixkarzinom in den FIGO Stadien
IB2 oder IIB (Tumorausbreitung parametran ohne
Harnstauung).
• Unterschriebene Einverständniserklärung.
• Keine vorangegangene maligne Erkrankung (außer
Basaliom der Haut).
• Keine vorherige Strahlentherapie.
• Keine vorherige Chemotherapie.
• Normale Nierenfunktion (Kreatinin-Clearance ≥60 ml/h) nach MDRD-Formel
• Narkosefähigkeit aus anästhesiologischer Sicht.
• Negativer Schwangerschaftstest maximal 7 Tage vor Therapiebeginn.
• Simultane Verwendung zweier zuverlässigen Verhütungsformen (z.B. orale Verhütung und Verwendung eines Kondoms) oder das Einhalten kompletter Abstinenz von heterosexuellem Kontakt während der gesamten Studienteilnahme (eingeschlossen Therapieunterbrechungen) und für den Zeitraum von 6 Monaten nach letzter Therapieintervention
• Verzicht auf das Stillen während der Studienteilnahme und einem Zeitraum 6 Monaten nach letzter Therapieintervention
• Monatliche Schwangerschaftstests
• Negative Hepatitis Serologie (HepB, HepC)
• Negativer HIV-Test

E.4

Principal exclusion criteria

• Fernmetastasierung (Ausnahme: histologisch
gesicherte paraaortale Lymphknotenmetastasen);
• Neuroendokrine Tumoren bzw. Mischtypen mit
neuroendokrinen Anteilen;
• Vormalige oder bestehende Zweitneoplasie; Ausnahme
Basaliom der Haut.
• Niereninsuffizienz (Kreatininclearance<60 ml/min) nach MDRD-Formel
• Psychiatrische oder neurologische Erkrankungen, die
eine Kooperationsfähigkeit nicht möglich machen;
• HIV-Infektion bzw. Aidserkrankung in der
Vorgeschichte, Drogenabhängigkeit bekannt;
• fehlende Bereitschaft zur Speicherung und Weitergabe
persönlicher Krankheitsdaten im Rahmen des
Protokolls, mangelnde Compliance- und fehlende
Bereitschaft zur Studie und regelmäßiger Nachsorge;
• Frühere Strahlentherapie des Beckens;
• Frühere Chemotherapie;
• Bestehende Schwangerschaft, Stillzeit, Frauen ohne
zuverlässige Kontrazeption während der
Radiochemotherapie;
• Schwere internistische Begleiterkrankung
(Myokardinfarkt, Kardiomyopathie, Herzinsuffizienz
NYHA III/IV, schwere COPD, nicht einstellbarer
Diabetes mellitus, unkontrollierte Infektionen).

• Kontraindikationen Carboplatin:
- bei Überempfindlichkeit gegen den Wirkstoff selbst, andere platinhaltige Verbindungen
-bei Patienten mit schwerer vorbestehen- der Nierenfunktionsstörung (Kreatinin- clearance <30 ml/min)
-bei Patienten mit einer schweren Knochenmarkschädigung
-bei Patienten mit blutenden Tumoren
-in der Stillzeit

• Kontarindikationen Paclitaxel:
-Überempfindlichkeit gegen den Wirkstoff, Macrogolglycerolricinoleat (Ph.Eur.) oder einen der sonstigen Bestandteile (Macrogolglycerolricinoleat(Ph.Eur., Ethanol).
-Paclitaxel sollte bei Patienten mit Neutro-philen-Ausgangswerten von < 1.500/mm3 (< 1.000/mm3 bei AIDS-Patienten) nicht angewendet werden.
-Paclitaxel ist auch kontraindiziert bei AIDS-Patienten mit bestehenden, schwerwiegenden und nicht behandelten Infektionen.
-Paclitaxel ist kontraindiziert während der Stillzeit.

• Kontraindikationen Cisplatin:
-Überempfindlichkeit gegen den Wirkstoff oder weitere Bestandteile (Wasser für Injektionszwecke, Natriumchlorid , Salzsäure 1 N zur pH-Einstellung, Natriumhydroxid 1 N zur pH-Einstellung) oder andere platinhaltige Arzneimittel.
-bei Patienten mit einer Myelosuppression, cisplatinbedingter Neuropathie,
-dehydrierten Patienten (zur Vorbeugung einer schwerwiegenden Nierenfunktionsstörung ist vor und nach der Anwendung eine Hydrierung erforderlich),
-bei Patienten mit vor- bestehender Niereninsuffizienz (Kreatinin- Clearance < 60 ml/min) oder einer Beeinträchtigung des Gehörs,
-Während einer Behandlung mit Cisplatin darf nicht gestillt werden.
-Die gleichzeitige Verabreichung von Gelb- fieberimpfstoff ist kontraindiziert
-Die Kombination mit prophylaktisch eingesetztem Phenytoin ist kontraindiziert

• Kontrainikationen Ifosphamid:
-Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile (Harnstoff, Natriumchlorid, Natriummonohydrogenphosphat-Dihydrat (Ph.Eur.), Salz- säure 36%, Wasser für Injektionszwecke,
-schwerer Beeinträchtigung der Knochenmarkfunktion (insbesondere bei zytostatisch und/oder strahlentherapeutisch vor- behandelten Patienten),
-floriden Infektionen,
-eingeschränkter Nierenfunktion und/oder Harnabflussbehinderungen,
-Blasenentzündung (Zystitis),
-Schwangerschaft und Stillzeit
-Wegen des Risikos einer möglichen ZNS- Toxizität von Ifosfamid ist eine sorgfältige Beobachtung des Patienten erforderlich. Im Falle einer Enzephalopathie ist die Behandlung mit Ifosfamid abzubrechen und auch nicht wieder aufzunehmen

E.5 End points

E.5.1

Primary end point(s)

Disease Free Survival (DFS):Als primäre Zielgröße wird das erkrankungsfreie Überleben (Disease free survival DFS ermittelt.

E.5.1.1

Timepoint(s) of evaluation of this end point

5 Jahre nach Therapieende

E.5.2

Secondary end point(s)

Overall Survival (OS), Lebensqualitätsanalyse, Toxizität

E.5.2.1

Timepoint(s) of evaluation of this end point

5 Jahre nach Thearpieende

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)

Yes

E.8 Design of the trial

E.8.1

Controlled

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

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

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

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:

534

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

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

534

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)

Therapie nach Standard of Care; klinischer Routine und im Ermessen des behandelnden Arztes

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

2019-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-14

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-08-09

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials