Clinical Trials Register

Summary
EudraCT Number:	2020-000435-45
Sponsor's Protocol Code Number:	Ver-A-T1D
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:	2021-06-07
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

2020-000435-45

A.3

Full title of the trial

A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-A-T1D)

Uno studio clinico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, in soggetti adulti con diabete mellito di tipo 1 neodiagnosticati che indaga l'effetto di Verapamil RP sulla conservazione della funzione beta-cellulare

A.3.1

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

A clinical trial in adults with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on the preservation of beta-cell function

Uno studio clinico in adulti neodiagnosticati con di diabete mellito di tipo 1 che studia l’effetto di Verapamil RP sulla conservazione della funzione delle beta cellule

A.3.2

Name or abbreviated title of the trial where available

Ver-A-T1D

A.4.1

Sponsor's protocol code number

Ver-A-T1D

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04545151

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	Medical University of Graz
B.1.3.4	Country	Austria
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	“Innovative Medicines Initiative 2” (Call IMI2-Call1: Grant Agreement Number 115797)
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	Medical University of Graz, Clinical Trials Unit
B.5.2	Functional name of contact point	Martina Brunner
B.5.3	Address:
B.5.3.1	Street Address	Stiftingtalstrasse 24
B.5.3.2	Town/ city	Graz
B.5.3.3	Post code	8010
B.5.3.4	Country	Austria
B.5.4	Telephone number	004331638572841
B.5.6	E-mail	martina.brunner@medunigraz.at

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	VeraHEXAL KHK 120 mg retard Retardtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
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	VeraHEXAL KHK 120 mg retard Retardtabletten
D.3.2	Product code	[VeraHEXAL KHK 120 mg retard Retardtabletten]
D.3.4	Pharmaceutical form	Prolonged-release capsule
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	VERAPAMIL CLORIDRATO
D.3.9.1	CAS number	52-53-9
D.3.9.2	Current sponsor code	VeraHEXAL KHK 120 mg retard Retardtabletten
D.3.9.4	EV Substance Code	SUB172220
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	120
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 1 diabetes mellitus(T1DM)

Diabete Mellito di Tipo 1 (T1DM)

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes

Diabete di tipo 1

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067584
E.1.2	Term	Type 1 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition 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 the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once daily versus placebo.

Determinare la variazione nella secrezione di C peptide dopo stimolo con pasto misto (MMTT) al basale e dopo 12 mesi di trattamento con Verapamil RP 360mg somministrato per via orale una volta al giorno contro placebo

E.2.2

Secondary objectives of the trial

To determine the effects of 360mg Verapamil SR administered orally once daily on fasting C-peptide and
Dried Blood Spot (DBS) C-peptide measurements over time.
To determine the effects of 360mg Verapamil SR administered orally once daily on HbA1c daily total insulin dose and continous glucose monitoring (CGM) time in range.
To determine the effects of treatment on other biomarkers related to immunological changes and
beta-cell death and survival in this population.
To determine the effects of 360mg Verapamil SR administered orally once daily on safety (vital signs,
ECG).

Determinare l’effetto della somministrazione orale di Verapamil RP 360 mg/die sui livelli basali di C-peptide misurato nel sangue e su goccia secca di sangue (DBS) nel tempo.
Determinare l’effetto della somministrazione orale di Verapamil RP 360 mg/die sui livelli di emoglobina glicata (HbA1C), sul fabbisogno insulinico giornaliero, e sul tempo trascorso con glicemia ottimale (time in range) come da monitoraggio glicemico continuo (CGM).
Determinare l’effetto del trattamento su altri biomarcatori immunologici e correlati alla morte/sopravvivenza beta cellulare.
Determinare la sicurezza della somministrazione di Verapamil RP 360mg/die sui parametri vitali e sull’ECG

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Have given written informed consent
• Age =18 and <45 years at consent
• Must have a diagnosis of T1D of within 6 weeks duration at screening (from date of the first insulin injection)
• Must have at least one or more diabetes-related autoantibodies present at screening
• Must have random C-peptide levels =200 pmol/L measured at screening
• Be willing to comply with intensive diabetes management

• Consenso informato scritto
• Età =18 e <45 anni al momento del consenso
• Diagnosi di T1D entro 6 settimane dallo screening (data della prima iniezione di insulina)
• Presenza di almeno uno o più autoanticorpi associati al diabete al momento dello screening
• Livelli di C-peptide a digiuno =100 pmol/L misurato al momento dello screening
• Disponibilità ad aderire ad una gestione intensiva del diabete

E.4

Principal exclusion criteria

• Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
• Have active signs or symptoms of acute infection at the time of screening
• Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
• Require use of immunosuppressive agents including chronic use of systemic steroids
• Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
• Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities as judged by the investigator
• Have a history of malignancies other than skin
• Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
• Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
• Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
• Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
• Current use of verapamil or other calcium channel blockers
• Known hypersensitivity to verapamil or to any of the excipients, use of beta-blockers in patients with poor ventricular function, concomitant ingestion of grapefruit juice, combination with ivabradine
• Hypotension (of less than 90mmHg systolic), sick sinus syndrome (except in patients with a functioning artificial pacemaker); uncompensated heart failure; marked bradycardia (less than 50 beats/minute), Wolff-Parkinson-
White syndrome, acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure
• ECG second or third degree atrioventricular block
• Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results

• Immunodeficienza o linfopenia cronica clinicamente significativa:
Leucopenia (<3,000 leucociti/µl), neutropenia (<1,500 neutrofili/µl), linfopenia (<800 linfociti/µl) o trombocitopenia (<100,000 piastrine/µl)
• Presenza di segni o sintomi di infezione acuta al momento dello screening
• Gravidanza o allattamento in corso o gravidanza prevista durante i 12 mesi dello studio
• Utilizzo di agenti immunosoppressivi, compresa l’assunzione cronica di steroidi sistemici.
• Evidenza di infezione in corso o pregressa da virus dell’immunodeficienza umana (HIV), virus dell’epatite B o dell’epatite C
• Presenza di qualsiasi patologia oppure di risultati clinici di laboratorio alterati che si ritiene possano interferire con la conduzione dello studio, o che potrebbero complicare patologie preesistenti: cardiopatia, malattia polmonare ostruttiva cronica (COPD), l'anemia drepanocitica, patologie neurologiche, anomalie emocromocitometriche secondo l’opinione dello sperimentatore
• Anamnesi di tumori maligni ad eccezione della pelle
• Evidenza di insufficienza epatica con valori di aspartato aminotransferasi (AST) o alanina transaminasi (ALT) che superano di oltre 3 volte i limiti superiori dei valori normali
• Anamnesi di insufficienza renale o evidenza di disfunzione renale con creatinina superiore a 1,5 volte il limite superiore della norma
• Uso, in corso o nei 7 giorni prima della visita di screening, di farmaci diversi dall’insulina, suscettibili di avere un impatto sul controllo glicemico
• Uso di qualsiasi altro farmaco in fase di sperimentazione nei 30 giorni precedenti e/o intenzione di utilizzare qualsiasi farmaco in fase di sperimentazione per la durata dello studio
• Uso attuale di Verapamil o altri tipi di farmaci della classe dei calcio-antagonisti
• Nota ipersensibilità al Verapamil o a qualsiasi componente del farmaco, utilizzo attuale di ß-bloccanti, consumo di succo di pompelmo, combinazione con ivabradina
• Ipotensione (pressione sistolica inferiore a 90mmHg), sindrome del seno malato (ad eccezione dei pazienti con pacemaker), insufficienza cardiaca non compensata; bradicardia marcata (inferiore a 50 battiti/min), sindrome di Wolff Parkinson-White, cardiomiopatia ipertrofica, infarto miocardico acuto, ipotensione marcata o grave disfunzione del ventricolo sinistro,
• ECG, blocco atrioventricolare di secondo o terzo grado
• Qualsiasi condizione che, a giudizio dello sperimentatore, possa influire negativamente sulla partecipazione allo studio o possa compromettere i risultati dello studio

E.5 End points

E.5.1

Primary end point(s)

Primary Outcome Measure:
1. Area under the stimulated C-peptide response curve
The primary objective is to determine the changes in stimulated C-peptide response during the first two hours of a
mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once
daily versus placebo.

1.Area sotto la curva della risposta del C-peptide stimolato
L'obiettivo primario è quello di determinare i cambiamenti nella risposta
alla stimolazione del C-peptide durante le prime due ore del test di
tolleranza al pasto misto (MMTT) al basale e dopo 12 mesi di terapia con
360mg Verapamil RP somministrato per via orale una volta al giorno
rispetto al placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

[Time Frame: At baseline and after 12 Months of therapy]

al basale e dopo 12 mesi di terapia

E.5.2

Secondary end point(s)

3. Proinsulin and preproinsulin secretion during the first two hours of a mixed meal
tolerance test (MMTT); Fasting C-peptide
To determine the effect of oral administration of Verapamil RP 360 mg
on C-peptide levels measured in fasting blood and on dry drop of
blood (DBS) over time; 5. DBS C-peptide
C-peptide in blood measured on dry blood drop (DBS) over time; 6. Change in HbA1c
Determine the effect of oral administration of Verapamil RP 360
mg/day on glycated hemoglobin (HbA1C) levels, daily insulin requirements, and time in range.
daily insulin requirements, and time spent with optimal glycemia (time in range)
as determined by continuous glucose monitoring (CGM); Number of treatment emergent severe hypoglycaemic episodes. Severe
hypoglycaemia denotes severe cognitive impairment requiring external
assistance for recovery according to the American Diabetes Association (ADA); Number of treatment emergent episodes of diabetic ketoacidosis (DKA); Change in insulin requirements, baseline to 12 months as the daily total dose
(three days average) in units per kg BW; Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A); CGM time in range (70-180 mg/dL, 3.9-10.0 mmol/L) and (70-140 mg/dL, 3.9-
7.8 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range
(<70 mg/dL, < 3.9 mmol/L); Secondary Outcome Measure:
2. The area under the stimulated C-peptide response curve over the first two hours
of a mixed meal tolerance test (MMTT)

3. La secrezione di proinsulina e preproinsulina
La secrezione di proinsulina e preproinsulina nelle prime due ore di un test
di tolleranza al pasto misto (MMTT); 4. C-peptide a digiuno
Determinare l’effetto della somministrazione orale di Verapamil RP 360 mg
sui livelli di C-peptide misurato a digiuno nel sangue e su goccia secca di
sangue (DBS) nel tempo; 5. DBS C-peptide
C-peptide nel sangue misurato su goccia secca di sangue (DBS) nel tempo; 6. Variazione dell’emoglobina glicata (HbA1c)
Determinare l’effetto della somministrazione orale di Verapamil RP 360
mg/die sui livelli di emoglobina glicata (HbA1C), sul fabbisogno insulinico
giornaliero, e sul tempo trascorso con glicemia ottimale (time in range)
come da monitoraggio glicemico continuo (CGM); 7. Episodi di ipoglicemici severi
Numero di episodi ipoglicemici severi ascrivibili al trattamento. Una
ipoglicemia grave è associata ad un deterioramento cognitivo importante
che richiede assistenza esterna ai fini della risoluzione secondo la American
Diabetes Association (ADA); 8. DKA
Numero di episodi di chetoacidosi diabetica ascrivibili al trattamento; 9.Variazioni nel fabbisogno insulinico
Variazioni nel fabbisogno insulinico dal basale ai 12 mesi in termini di dose
giornaliera complessiva (media su tre giorni) espressa in unità per
chilogrammo di peso corporeo (BW); 10. Variazione degli autoanticorpi associati al T1D
Variazione degli autoanticorpi associati al T1D (GADA, IAA, IA-2 e ZnT8) dal
basale ai 12 mesi
]; 11. Monitoraggio continuo del glucosio (CGM)
Tempo durante il quale il monitoraggio continuo del glucosio (CGM) rientra
negli intervalli ottimali, (70-140mg/dL, 3.9-7.8 mmol/L) e (70-180mg/dL,
3.9-10.0 mmol/L), tempo in cui i valori sono superiori a quelli previsti
(>180mg/dL, >10.0 mmol/L), tempo in cui i valori sono inferiori a quelli
previsti (<70mg/dL, < 3.9 mmol/L); End Point Secondario
2. Area sotto la curva della risposta del C-peptide stimolato
L’area sotto la curva della risposta del C-peptide stimolato nel corso delle
prime due ore di un test di tolleranza al pasto misto (MMTT)

E.5.2.1

Timepoint(s) of evaluation of this end point

[Time period: at baseline, and 3, 6, 9 months, and 12 months].; [Time period: at baseline and after 12 months of therapy].; at all observation times; [Time period: baseline to 12 months and baseline to 24 months].; [Time period: baseline to 12 months].; [Time period: baseline to 12 months].; [Time period: baseline to 12 months and baseline to 24 months].; [Time period: baseline to 12 months]; [Time period: baseline to 12 months].; [Time Frame: At baseline, and 3, 6, 9 and 24 months]

[Periodo di tempo: al basale, e 3, 6, 9 mesi e 12 mesi]; [Periodo di tempo: al basale e dopo 12 mesi di terapia]; [Periodo di tempo: tutto il periodo di osservazione]; [Periodo di tempo: dal basale a 12 mesi e dal basale a 24 mesi]; [Periodo di tempo: dal basale a 12 mesi]; [Periodo di tempo: dal basale a 12 mesi]; [Periodo di tempo: dal basale a 12 mesi e dal basale a 24 mesi]; [Periodo di tempo: dal basale a 12 mesi; [Periodo di tempo: dal basale a 12 mesi]; [Periodo di tempo: al basale, e 3, 6, 9 mesi e 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

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Austria

Belgium

France

Germany

Italy

Poland

Sweden

United Kingdom

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:

120

F.1.3

Elderly (>=65 years)

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

120

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)

No post treatment planned.
A follow-up visit is planned 12 months after study completion (optional for the subjects)

Non è prevista una specifica assistenza ai pazienti al termine della loro partecipazione allo studio.
Viene proposta una ulteriore visita di controllo 12 mesi dopo il termine dello studio (facoltativa).

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	INNODIA
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

2021-08-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-12

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