Clinical Trials Register

Summary
EudraCT Number:	2015-001663-39
Sponsor's Protocol Code Number:	D4190C00022
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001663-39

A.3

Full title of the trial

A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination with Tremelimumab or Bevacizumab in Subjects with Advanced Hepatocellular Carcinoma

Studio sulla sicurezza, tollerabilità e attività clinica di Durvalumab e Tremelimumab somministrati in monoterapia, o Durvalumab in combinazione con Tremelimumab o Bevacizumab a soggetti con carcinoma epatocellulare avanzato

A.3.1

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

A clinical trial in patients with advanced liver cancer. The trial will investigate the safety, tolerability and clinical activitiy of durvalumab or tremelimumab as monoterapy, durvalumab combined with tremelimumab, or durvalumab combined with bevacizumab

Sperimentazione clinica su pazienti con carcinoma epatico avanzato. Lo studio valuterà la sicurezza, la tollerabilità e l’attività clinica di Durvalumab o Tremelimumab in monoterapia, di Durvalumab in combinazione con Tremelimumab, o di Durvalumab in combinazione con Bevacizumab.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

D4190C00022

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02519348

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	MEDIMMUNE, LLC
B.1.3.4	Country	United States
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	Medimmune, Limited
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MedImmune, LCC
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	One MedImmune Way
B.5.3.2	Town/ city	Gaithersburg
B.5.3.3	Post code	20878
B.5.3.4	Country	United States
B.5.4	Telephone number	0018772409479
B.5.5	Fax number	000000
B.5.6	E-mail	information.center@astrazeneca.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	Tremelimumab
D.3.2	Product code	[MEDI1123]
D.3.4	Pharmaceutical form	Concentrate 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	Tremelimumab
D.3.9.1	CAS number	745013-59-6
D.3.9.2	Current sponsor code	MEDI1123
D.3.9.3	Other descriptive name	Human cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Durvalumab
D.3.2	Product code	[MEDI4736]
D.3.4	Pharmaceutical form	Concentrate 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.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.9.3	Other descriptive name	Immunoglobulin G1, anti-(human CD antigen
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	NA
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Concentrate 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	BEVACIZUMAB
D.3.9.2	Current sponsor code	NA
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	25
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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

Hepatocellular Carcinoma

Carcinoma epatocellulare

E.1.1.1

Medical condition in easily understood language

Liver Cancer

Carcinoma epatico

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	LLT
E.1.2	Classification code	10019828
E.1.2	Term	Hepatocellular carcinoma non-resectable
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

To assess the safety and tolerability of durvalumab and tremelimumab administered as monotherapy and durvalumab in combination with tremelimumab or bevacizumab in subjects with advanced HCC.

Valutare la sicurezza e la tollerabilità di durvalumab e tremelimumab somministrati in monoterapia e durvalumab in combinazione a tremelimumab o bevacizumab in soggetti con carcinoma epatocellulare (HepatoCellular Carcinoma, HCC) avanzato

E.2.2

Secondary objectives of the trial

1.To evaluate the efficacy of durvalumab and tremelimumab administered as monotherapy, and durvalumab in combination with tremelimumab or bevacizumab in subjects with advanced HCC.
2. To evaluate the relationship between candidate biomarkers (eg, PD-L1 expression in the tumor microenvironment) and measures of clinical outcome of durvalumab and tremelimumab administered as monotherapy, and durvalumab in combination with tremelimumab or bevacizumab in subjects with advanced HCC.

1. Valutare l’efficacia di durvalumab e di tremelimumab somministrati in monoterapia e durvalumab in combinazione a tremelimumab o bevacizumab in soggetti con HCC avanzato
2. Valutare la correlazione tra i biomarcatori candidati (per es. espressione del ligando 1 della morte cellulare programmata [PDL1] nel microambiente del tumore) e misure di esito clinico di durvalumab e tremelimumab somministrati in monoterapia e durvalumab in combinazione a tremelimumab o bevacizumab in soggetti con HCC avanzato.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subjects
2. 18 years and older
3. Confirmed HCC based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
4. Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved VEGFR TKI. Part 4 only: Must not have received prior systemic therapy for HCC.

1. Soggetti maschili o femminili
2. Età pari o superiore ai 18 anni
3. HCC confermato in base ai risultati istopatologici da tessuti tumorali. HCC avanzato con diagnosi confermata patologicamente o con metodi non invasivi.
4. I soggetti devono essere naive all'immunoterapia e devono: avere avuto una progressione della malattia, essere intolleranti a o avere rifiutato il trattamento con sorafenib o altro TKI anti-VEGFR approvato. Solo Parte 4: non pregressa terapia sistemica per HCC.

E.4

Principal exclusion criteria

1. Prior exposure to immune-mediated therapy
2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
3. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months.
4. Ascites requiring nonpharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose.
5. Main portal vein thrombosis (Vp4) as documented on imaging
6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
7. Active or prior documented autoimmune or inflammatory disease with some exceptions
8. Current or prior use of immunosuppressive medication within 14 days of first dose of IP, with some exceptions

1. Precedente esposizione a terapia immunomediata
2. Encefalopatia epatica negli ultimi 12 mesi o necessità di medicinali per prevenire o tenere sotto controllo l'encefalopatia.
3. Sanguinamento GI (ad es. varici esofagee o sanguinamento da ulcera) negli ultimi 12 mesi.
4. Ascite che richiede intervento non farmacologico per mantenere sotto controllo i sintomi, entro 6 mesi prima della prima dose programmata.
5. Trombosi della principale vena porta (Vp4) documentata mediante diagnostica per immagini.
6. Chemioterapia, immunoterapia, o terapia biologica od ormonale concomitanti per il trattamento di un carcinoma.
7. Patologia infiammatoria o autoimmune, attiva o documentata in precedenza con alcune eccezioni
8. Farmaco immunosoppressore assunto attualmente o nei precedenti 14 giorni precedenti la prima dose di Farmaco Sperimentale, con alcune eccezioni.

E.5 End points

E.5.1

Primary end point(s)

- Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events.

- Number (percentage) of subjects discontinuing investigational product(s) due to toxicity.

- Changes from baseline in laboratory parameters (including liver and viral laboratory tests), electrocardiograms and vital signs.

- Numero (percentuale) dei soggetti che riferiscono eventi avversi e numero (percentuale) dei soggetti che riferiscono eventi avversi seri.

- Numero (percentuale) di soggetti che interrompono l'assunzione del(dei) prodotto(i) sperimentale(i) a causa della tossicità.

- Variazioni dal basale dei parametri di laboratorio (inclusi esami epatici e virali), elettrocardiogrammi e segni vitali.

E.5.1.1

Timepoint(s) of evaluation of this end point

Screening through 3 months after the last dose of study medication

Screening per 3 mesi dopo l’ultima dose del farmaco dello studio

E.5.2

Secondary end point(s)

1. Objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS) based on investigator assessments and Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS).
2. AEs, SAEs, discontinuation of investigational product(s) due to toxicity, and changes from baseline in laboratory parameters (including liver and viral laboratory tests), ECG, and vital signs in 3 distinct HCC
populations: uninfected, HBV+, and HCV+.
3. PD-L1 expression within the tumor microenvironment.

1. Tasso di risposta obiettiva (Objective Response, ORR), tasso di controllo della malattia (Disease Control, DCR), tempo alla risposta (TTR), durata della risposta (DoR), tempo alla progressione (TTP), Progression-Free Survival (PFS) basati sulle valutazioni dello sperimentatore e sul Riesame centrale indipendente in cieco (Blinded Independent Central Review, BICR) tenendo conto dei Criteri di valutazione della risposta nei tumori solidi (Response Evaluation Criteria In Solid Tumors, RECIST) v1.1, e sopravvivenza globale (Overall Survival, OS).
2. Eventi avversi (EA), eventi avversi gravi (Serious Adverse Events, SAE), interruzione del/dei prodotto/i sperimentale/i dovuta a tossicità e variazioni rispetto al basale nei parametri di laboratorio (inclusi gli esami di laboratorio epatici e virali), elettrocardiogrammi (ECG) e segni vitali in 3 diverse popolazioni di soggetti con epatocarcinoma (Hepatocellular Carcinoma, HCC): non infetti, HBV+ e HCV+.
3. Espressione di PD-L1 nel microambiente del tumore.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. ORR: Screening through 12 months after the last subject is randomized
2. DoR: Screening through 12 months after the last subject is randomized
3. OS: Screening through 12 months after the last subject is randomized
4. PD-L1 expression: Screening through last dose of study medication
5. TTP: From date of first dosing to the first documentation of radiographic progression (per RECIST v1.1)
6. PFS: Time from the date of first dosing to the first documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first
7. DCR: Screening through 12 months after last subject is randomized
8. TTR: Time from the first dose of investigational product to the first documentation of a subsequently confirmed objectivve response assessed up to 24 months

1-2-3: ORR-DoR-OS: screening nel corso dei 12 mesi successivi alla randomizzazione dell’ultimo soggetto
4. Espressione di PD-L1: screening nel corso dell’ultima dose di prodotto sperimentale
5. TTP: dalla data del primo dosaggio alla prima documentazione radiografica di progressione della malattia (come da RECIST v 1.1)
6. PFS: dalla data del primo dosaggio alla prima documentazione radiografica di progressione della malattia (come da RECIST v 1.1) o decesso per qualsiasi causa, a seconda dell'evento che si verifica per primo
7. DCR: screening nel corso dei 12 mesi successivi alla randomizzazione dell’ultimo soggetto
8. TTR: dalla prima dose di prodotto sperimentale alla prima documentazione di una risposta obiettiva successivamente confermata valutabile fino a 24 mesi

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

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

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

Information not present in EudraCT

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

Hong Kong

Japan

Korea, Republic of

Singapore

Taiwan

United States

Italy

Spain

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

As per protocol: 'The end of the study ("study completion") is defined when the last patient discontinues study treatment.'

Come da protocollo: “Il termine dello studio (‘completamento dello studio’) corrisponde a quando l’ultimo paziente avrà interrotto il trattamento

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:

292

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

164

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

A legal representative may provide consent on behalf of a subject incapable of giving consent, where permitted

Un rappresentante legale può fornire il consenso per conto di un soggetto non in grado di farlo, quando permesso.

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

F.4.2.2

In the whole clinical trial

456

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)

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

2015-12-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-28

P. End of Trial
P.	End of Trial Status	Ongoing

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