Clinical Trials Register

Summary
EudraCT Number:	2020-002234-32
Sponsor's Protocol Code Number:	CONVINCE
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-01-04
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002234-32

A.3

Full title of the trial

Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19)

Studio clinico per valutare l’efficacia e la sicurezza di Edoxaban e/o Colchicina in pazienti affetti da SARS-CoV-2 gestiti in ambiente extra ospedaliero (COVID 19)

A.3.1

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

Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19)

Studio clinico per valutare l’efficacia e la sicurezza di Edoxaban e/o Colchicina in pazienti affetti da SARS-CoV-2 gestiti in ambiente extra ospedaliero (COVID 19)

A.3.2

Name or abbreviated title of the trial where available

CorONa Virus edoxabaN ColchicinE (CONVINCE)

A.4.1

Sponsor's protocol code number

CONVINCE

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	INSEL GRUPPE AG, BERN UNIVERSITY HOSPITAL, DEPARTMENT OF CARDIOLOGY
B.1.3.4	Country	Switzerland
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	Daiichi Sankyo Europe GmbH
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	Insel Gruppe AG, Bern University Hospital Department of Cardiology
B.5.2	Functional name of contact point	Cardiologia
B.5.3	Address:
B.5.3.1	Street Address	Freiburgstrasse, 8
B.5.3.2	Town/ city	Bern
B.5.3.3	Post code	3010
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41316325492
B.5.6	E-mail	marco.valgimigli@insel.ch

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.2.1.1.1	Trade name	Lixiana 30mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
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	Edoxaban
D.3.2	Product code	[Edoxaban]
D.3.4	Pharmaceutical form	Film-coated 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.3.9.1	CAS number	912273-65-5
D.3.9.2	Current sponsor code	Edoxaban
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	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	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	Colchicine
D.2.1.1.2	Name of the Marketing Authorisation holder	Tiofarma B. V.
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	Colchicine
D.3.2	Product code	[M04AC01]
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.3.9.1	CAS number	64-86-8
D.3.9.2	Current sponsor code	Colchicine
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	500
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	Yes
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	Yes
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	Lixiana 60mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
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	Edoxaban
D.3.2	Product code	[Edoxaban]
D.3.4	Pharmaceutical form	Film-coated 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.3.9.1	CAS number	912273-65-5
D.3.9.2	Current sponsor code	Edoxaban
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	60
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	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	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 with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.

Pazienti con diagnosi di laboratorio (attraverso RT-PCR) di SARS-COV-2 gestiti a domicilio o in ambiente extra ospedaliero

E.1.1.1

Medical condition in easily understood language

Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.

Pazienti con diagnosi di laboratorio (attraverso RT-PCR) di SARS-COV-2 gestiti a domicilio o in ambiente extra ospedaliero

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
E.1.2	System Organ Class	100000004862

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 aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR

Valutare la sicurezza e l’efficacia della somministrazione di edoxaban e/o colchicina nei pazienti affetti da SARS-CoV-2 gestiti in ambiente extra ospedaliero in merito al numero di decessi, ricoveri ospedalieri, eventi trombotici vascolari maggiori o grado di clearance di SARS-CoV-2 attraverso RT-PCR

E.2.2

Secondary objectives of the trial

N.A.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients >= 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.

Pazienti >= 18 anni con sintomi compatibili con infezione attiva da Coronavirus e diagnosi di laboratorio (attraverso RT-PCR) di SARS-COV-2 gestiti a domicilio o in ambiente extra ospedaliero.

E.4

Principal exclusion criteria

• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including Child-Pugh C cirrhosis with portal hypertension.
• Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
• Uncontrolled severe hypertension.
• Ongoing or planned treatment with parenteral or oral anticoagulants
• Unilateral or bilateral above knee lower extremity amputation.
• Inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures
• Have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
• Pregnancy or breast-feeding or any plan to become pregnant during the study. Women (and men, for Colchicine group only) with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible, both partners should use adequate barrier birth control).
• Need for dual anti-platelet therapy consisting of aspirin and an oral P2Y12 inhibitor
• Inflammatory bowel disease or chronic diarrhea or neuromuscular disease
• Creatinine clearance (CrCl) <15 ml/min
• Anticipated use of Hydroxychloroquine
• Participation in any other clinical trial
• Inability to understand the requirements of the study and to provide informed consent

• Malattia epatica associata a coagulopatia e rischio di sanguinamento clinicamente rilevante, inclusa cirrosi con ipertensione portale (classe C Child-Pugh)
• Lesione o condizione considerata un rischio significativo di sanguinamento maggiore. Può includere ulcerazione gastrointestinale corrente o recente, presenza di neoplasia maligna ad
alto rischio di sanguinamento, recente lesione cerebrale o spinale, recente intervento chirurgico cerebrale, spinale o oftalmico, recente emorragia intracranica, varici esofagee note o
sospette, malformazioni aterovenose, aneurismi vascolari o anomalie vascolari intraspinali o intracerebrali
• Ipertensione severa non controllata
• Trattamento in corso o in programma con anticoagulanti per via parenterale o orale
• Amputazione dell’arto inferiore sopra il ginocchio unilaterale o bilaterale
• Incapacità ad assumere farmaci per via orale o incapacità/indisponibilità ad essere sottoposti alle procedure previste dallo studio
• Aver ricevuto o ricevere un farmaco sperimentale o utilizzare un dispositivo medico sperimentale entro 30 giorni prima dell’inizio del previsto trattamento
• Donne in gravidanza o in allattamento o che pianificano una gravidanza durante lo studio Le donne (e gli uomini solo per il gruppo della colchicina) in età fertile che non stanno utilizzando un metodo anticoncezionale adeguato (come metodo anticoncezionale adeguato si raccomanda la contraccezione orale; se la contraccezione orale non è fattibile, entrambi i partners dovrebbero usare un adeguato metodo contracettivo a barriera)
• Necessità di una doppia terapia anti-piastrinica composta da aspirina e da un inibitore orale P2Y12
• Malattia infiammatoria intestinale o diarrea cronica o malattia neuromuscolare
• Clearance della creatinina (CrCl) < 15 ml/min
• Impiego previsto di idrossiclorochina
• Partecipazione ad un altro studio clinico
• Soggetti non in grado di comprendere i requisiti dello studio o di fornire il consenso informato

E.5 End points

E.5.1

Primary end point(s)

This study has 2 co-primary endpoints, one each randomization as follows:

Edoxaban vs. no active treatment
Major vascular thrombotic events (MVTE) at 25 (+/-3) days defined as a composite of:
• Asymptomatic proximal deep-vein thrombosis
• Symptomatic proximal or distal deep-vein thrombosis
• Symptomatic pulmonary embolism or thrombosis
• Myocardial infarction
• Ischemic stroke
• non-CNS systemic embolism
• Death

Colchicine vs no active treatment
The SARS-CoV-2 detection rates at day 14 (+/-3) under RT PCR or freedom from death or hospitalisation

Questo studio clinico ha due endpoint primari, uno per ogni randomizzazione, come segue:
- Edoxaban versus nessun trattamento attivo

Eventi trombotici vascolari maggiori (MVTE) a 25(+/-3) giorno definiti come un composto di:
- trombosi venosa profonda asintomatica prossimale
- Sintomatica trombosi venosa profonda prossimale o distale
- Embolia polmonare sintomatica o trombosi
- Infarto Miocardio
- Ictus Ischemico
- Embolia sistemica del sistema nervoso non centrale
- Morte

Colchicina versus nessun trattamento attivo
Clearance di SARS-CoV-2 valutata attraverso RT-PCR o assenza di morte o ospedalizzazione a 14 (+/- 3) dalla randomizzazione

E.5.1.1

Timepoint(s) of evaluation of this end point

14 (+/-3) and 25 (+/-3) days

14 (+/-3) e 25 (+/-3) giorni

E.5.2

Secondary end point(s)

The secondary endpoints of the study are the following:
1) Each component of the co-primary endpoints
2) Need for non-invasive or invasive ventilation
3) Need for oxygen therapy
4) Body temperature kinetics
5) Need for analgesics including NSAIDs and/or paracetamol
6) Need for hospitalisation and total days in the hospital
7) Any combination of the above endpoints
8) Each component of the primary endpoint as well as pre-specified composite endpoints at the time all SAEs have come to a resolution
9) Impact of either intervention on coagulation and inflammatory biomarkers including IL-6, CRP, D-dimers, sCD40L, Fibrinogen, Factor X activity and Factor XIa
10) EKG analyses for QT segment measures and for detection of EKC changes associated to myopericarditis.
11) HsTroponin levels
12) Bleeding endpoints according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 and ISTH major and clinically relevant non-major bleeding

Gli endpoint secondari sono:
- Componenti individuali di ciascun endpoint primario composito
- Necessità di ventilazione non-invasiva o invasiva
- Necessità di ossigenoterapia
- Andamento della temperatura corporea
- Necessità di analgesici inclusi FANS e/o paracetamolo
- Necessità di ricovero ospedaliero e totali giorni di degenza ospedaliera
- Qualsiasi combinazione degli endpoints soprariportati
- Ogni componente dell’Endpoint primario così come gli endpoints compositi prespecificati al momento della risoluzione di tutti i SAEs
- Impatto di entrambi gli interventi sui biomarkers della coagulazione e infiammatori tra cui IL-6, CRP, D-Dimero, sCD40L, fibrinogeno, attività del Fattore X e fattore XIa
- Analisi elettrocardiografica del tratto QT e dei cambiamenti elettrocardiografici associati a mio-pericardite
- Livelli di Troponina Hs
- Sanguinamenti BARC 2,3 o 5 e sanguinamenti ISTH maggiori e non maggiori clinicamente rilevanti

E.5.2.1

Timepoint(s) of evaluation of this end point

14 (+/-3) and 25 (+/-3) days; 14 (+/-3) e 25 (+/-3) giorni

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)

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

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

Belgium

Italy

Spain

Switzerland

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

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

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

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

380

F.4.2.2

In the whole clinical trial

420

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)

There are no specific post-study treatment or post-study care programmes

Non sono previsti specifici programmi di trattamento o assistenza successivi al termine dello studio

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

2020-10-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-08-31

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IMP with orphan designation in the indication
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