Clinical Trials Register

Summary
EudraCT Number:	2020-003959-16
Sponsor's Protocol Code Number:	CAAA405A12301
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-03-17
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

France - ANSM

A.2

EudraCT number

2020-003959-16

A.3

Full title of the trial

Phase III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging in patients with prostate cancer with rising PSA levels [biochemical recurrence (BCR)] (GuidePath)

Etude de phase III évaluant la performance diagnostique de la tomographie par émission de positrons avec le [18F]CTT1057 chez des patients atteints d'un cancer de la prostate et présentant une augmentation du PSA [récidive
biochimique (RBC)] (GuidePath)

A.3.1

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

Diagnostic performance of [18F]CTT1057 PET in BCR

Performance diagnostique de laTEP avec le [18F]CTT1057 en RBC

A.3.2

Name or abbreviated title of the trial where available

GuidePath

A.4.1

Sponsor's protocol code number

CAAA405A12301

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	Novartis Pharma AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma S.A.S
B.5.2	Functional name of contact point	Information&Communication Médicales
B.5.3	Address:
B.5.3.1	Street Address	8/10 rue Henry Sainte Claire Deville
B.5.3.2	Town/ city	Rueil-Malmaison
B.5.3.3	Post code	92500
B.5.3.4	Country	France
B.5.4	Telephone number	+33 1 5547 6600
B.5.5	Fax number	+33 1 5547 6100
B.5.6	E-mail	icm.phfr@novartis.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	No
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	PSMA-11 25 μg, Kit for radiopharmaceutical preparation
D.3.2	Product code	AAA517
D.3.4	Pharmaceutical form	Kit for radiopharmaceutical preparation
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	gallium (68Ga) gozetotide
D.3.9.2	Current sponsor code	AAA517
D.3.9.4	EV Substance Code	SUB219371
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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	Yes
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	No
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	[18F]CTT1057
D.3.2	Product code	AAA405
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	not yet available
D.3.9.2	Current sponsor code	AAA405
D.3.9.3	Other descriptive name	(2S)-2-[[[(4S)-4-carboxy-4-[[(4S)-4-carboxy-4-[6-[(4-(18F)fluoranylbenzoyl)amino]hexanoylamino]butanoyl]amino]butoxy]-hydroxyphosphoryl]amino]pentanedioic acid
D.3.9.4	EV Substance Code	SUB221208
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	370
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	Yes
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

Prostate cancer with rising PSA levels [biochemical recurrence (BCR)]

Cancer de la prostate présentant une augmentation du PSA [récidive biochimique (RBC)]

E.1.1.1

Medical condition in easily understood language

Prostate cancer

Cancer de la prostate

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10036911
E.1.2	Term	Prostate cancer recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 co-primary objectives of this study are
• to evaluate the region-level correct localization rate (CLR) of [18F]CTT1057
• to evaluate the patient-level positive predictive value (with anatomical localization) of [18F]CTT1057

Evaluer le taux de localisation correct du [18F]CTT1057 au niveau des régions anatomiques

Evaluer la valeur prédictive positive du [18F]CTT1057 au niveau du patient (avec localisation anatomique)

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are :
• To evaluate the patient-level sensitivity of [18F]CTT1057
• To evaluate the patient-level specificity of [18F]CTT1057
• To evaluate the patient-level negative predictive value of [18F]CTT1057
• To evaluate the patient-level accuracy of [18F]CTT1057
• To evaluate the region level sensitivity of [18F]CTT1057
• To evaluate the region level specificity of [18F]CTT1057
• To evaluate the region level negative predictive value of [18F]CTT1057
• To evaluate the region level accuracy of [18F]CTT1057
• To evaluate correct detection rate (CDR)
• To evaluate detection rate
• To evaluate the patient-level positive predictive value related to PSA levels
• To characterize the safety and tolerability of [18F]CTT1057
• [18F]CTT1057 scan inter-reader variability
• [18F]CTT1057 scan intra-reader variability

other protocol-defined secondary objectives may apply.

Objectif secondaire clé:
Evaluer la sensibilité du [18F]CTT1057 au niveau patient;
Evaluer la spécificité du [18F]CTT1057 au niveau patient;
Evaluer la valeur prédictive négative du [18F]CTT1057 au niveau patient;
Evaluer la précision du [18F]CTT1057 au niveau patient;
Evaluer la sensibilité du [18F]CTT1057 au niveau de la region;
Evaluer la spécificité du [18F]CTT1057 au niveau de la region;
Evaluer la valeur prédictive négative du [18F]CTT1057 au niveau de la region;
Evaluer la précision du [18F]CTT1057 au niveau de la region;
Evaluer le taux de détection correct;
Evaluer le taux de detection;
Evaluer la valeur prédictive positive liée aux taux de PSA au niveau patient;
Caractériser la sécurité et la tolérance du [18F]CTT1057
[18F]CTT1057 la variabilité inter-lecteurs 
[18F]CTT1057 la variabilité intra-lecteur

D'autres obectifs secondaires définis par le protocole peuvent être applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Biopsy proven prostate adenocarcinoma.
3. Biochemical recurrence defined by American Urological Association (AUA) criteria for patients who have undergone radical prostatectomy (detectable or rising PSA value measured 6–13 wk after surgery, that is ≥0.2 ng/mL with a second determination of a PSA level>0.2 ng/mL at least 2 week apart) and by American Society for Radiation Oncology (ASTRO)-Phoenix criteria for patients who have undergone curative-intent radiotherapy (PSA≥2 ng/mL above the nadir).
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Participants must be adults ≥ 18 years of age

1. La signature du consentement éclairé doit être obtenue avant toute procédure de l’étude.
2. Adénocarcinome de la prostate confirmé par biopsie.
3. Récidive biochimique définie par les critères AUA pour les patients
ayant subi une prostatectomie radicale (PSA détectable ou en augmentation dosé 6 à 13 semaines après la chirurgie, soit ≥ 0,2 ng/mL avec un second dosage avec un taux de PSA> 0,2 ng/mL à au moins 2 semaines d'intervalle) et selon les critères ASTRO-Phoenix pour les patients ayant subi une radiothérapie à visée curative (PSA ≥
2 ng/mL au-dessus du nadir).
4. Indice de performance ECOG (pour Eastern Cooperative Oncology Group) entre 0 et 2.
5. Patients adultes âgés ≥ 18 ans.

E.4

Principal exclusion criteria

1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reasons (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and Coronavirus Disease 2019 (COVID-19)
3. Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
4. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057, [68Ga]Ga-PSMA-11, or to CT contrast
5. Prior and current use of PSMA targeted therapies
6. Prior and current treatment with Luteinizing Hormone-Releasing Hormone (LHRH) analogues
7. Any prior ADT (first or second generation) within 9 months before screening
8. Any 5-alpha reductase inhibitors within 30 days before screening
9. Use of other investigational drugs within 30 days before screening
10. Castration-resistant patients
11. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue

1. Incapacité à passer des examens d'imagerie expérimentale et standard requis quelle qu’en soit la raison (claustrophobie sévère, incapacité à rester immobile pendant toute la durée de l'examen, etc.).
2. Toute comorbidité, maladie intercurrente grave, cancer concomitant ou autre circonstance qui, d’après l'investigateur, ferait prendre un risque important pour la sécurité du patient ou compromettrait sa participation à l'étude, y compris, mais sans s'y limiter, incontinence urinaire sévère, hydronéphrose, dysfonctionnement mictionnel sévère, sonde à demeure/condom urinaire, insuffisance cardiaque congestive de classe III ou IV de la New York Heart Association, antécédents de syndrome du QT long congénital, infection incontrôlée, hépatite B ou C active et la COVID-19.
3. Intervention chirurgicale majeure moins de 12 semaines avant la sélection (à l'exception des interventions chirurgicales liées au cancer de la prostate).
4. Allergie, hypersensibilité ou intolérance connue au [18F]CTT1057, au [68Ga]Ga-PSMA-11 ou aux produits de contraste du CT-scan.
5. Utilisation antérieure et en cours de traitements ciblant le PSMA.
6. Traitement antérieur et en cours par des analogues de la LHRH.
7.Tout traitement anti-androgénique (première ou deuxième génération) dans les 9 mois précédant la selection.
8. Tout traitement inhibiteur de la 5-alpha réductase dans les 30 jours précédant la sélection.
9. Administration d’autres médicaments à l’essai dans les 30 jours précédant la sélection.
10. Patients résistants à la castration.
11. Patients présentant un adénocarcinome de la prostate à petites cellules ou neuroendocrine dans plus de 50% des tissus de biopsie.

E.5 End points

E.5.1

Primary end point(s)

• Proportion of regions containing at least one TP lesion (anatomically localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings within the same region, out of all regions containing at least one PET-positive finding by central assessments.

• Proportion of patients who have at least one TP lesion (anatomically localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are PET/CT scan positive by central assessments.

•Proportion de régions contenant au moins une lésion vraie positive (VP) (avec une correspondance de localisation exacte entre l'imagerie TEP et le standard de référence), indépendamment de tout résultat faux positif (FP) coexistant dans la même région, parmi toutes les régions contenant au moins un résultat positif au TEP.

•Proportion de patients qui présentent au moins une lésion vraie positive (VP) (avec une correspondance de localisation exacte entre l'imagerie TEP et le standard de référence), indépendamment des résultats faux positif (FP) coexistants, parmi tous les patients positifs au TEP/CT-scan

E.5.1.1

Timepoint(s) of evaluation of this end point

For both co-primary endpoints [18F]CTT1057 PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)

E.5.2

Secondary end point(s)

• Proportion of patients that test positive on [18F]CTT1057 and CTS (TP) among those that are CTS positive (TP or FN)
• Proportion of patients that test negative on [18F]CTT1057and CTS (TN) among those that are CTS negative (TN or FP)
• Proportion of patients who are both [18F]CTT1057 and CTS negative (TN) among those who test negative on [18F]CTT1057 (TN or FN)
• Proportion of patients that are CTS and [18F]CTT1057 positive (TP) and negative (TN) among those patients that identified on [18F]CTT1057 (TP, TN, FP or FN)
• Proportion of patients who have at least one TP lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are scanned
• Proportion of patients who have at least one PET positive lesion, regardless of TP or FP findings, out of all patients who are scanned
• Proportion of regions that test positive on both [18F]CTT1057 and CTS (TP) among those regions that are CTS positive (TP or FN)
• Proportion of regions that test negative on both [18F]CTT1057 and CTS (TN) among those regions that are CTS negative (FP, or TN)
• Proportion of regions that are CTS and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN or FN)
• Proportion of regions that are CTS and [18F]CTT1057 positive (TP) and negative (TN) among those regions that identified on [18F]CTT1057 (TP, TN, FP and FN)
• Percentage of patients who have at least one TP lesion (exactly anatomically localized correspondence between [18F]CTT1057 PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are [18F]CTT1057 positive, stratified by PSA levels
• Incidence of AEs after each PET tracer injection, after each PET/CT scan and at 24-72 h after each PET/CT scan. Treatment emergent adverse event (TEAE) rate within 14 days after each PET tracer administration
• Inter-reader agreement of [18F]CTT1057 images
• Intra-reader agreement of [18F]CTT1057 images
• Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of positivity at patient level using central reads
• Percentage of patients who underwent a change in intended treatment plan attributed to the PET/CT scan as assessed by pre and post imaging questionnaires
• All the above primary and secondary endpoints independently in the subgroup of patients post-prostatectomy and the subgroup of patients after prostate radical RT

E.5.2.1

Timepoint(s) of evaluation of this end point

For majority of secondary endpoints [18F]CTT1057 PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment).

Safety endpoints will be collected from up to 28 days prior first study medication administration to 14 days after second study medication administration.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

Tolerability

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

E.8.1.1

Randomised

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

Yes

E.8.1.7.1

Other trial design description

prospective, open-label, multi center, single-arm study

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

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

United States

France

Spain

Switzerland

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

Study completion is defined as when the last participant finishes the last visit for the study or, in the event of an early study termination decision, the date of that decision.

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:

133

F.2 Gender

F.2.1

Female

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

125

F.4.2.2

In the whole clinical trial

190

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)

none

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

2021-04-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-11-23

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