Clinical Trials Register

Summary
EudraCT Number:	2019-004019-29
Sponsor's Protocol Code Number:	CRACCA-2019
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:	2020-10-07
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-004019-29

A.3

Full title of the trial

Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study.

Studio prospettico randomizzato multicentrico sull’efficacia della terapia di combinazione con acido retinoico e cabergolina in pazienti con adenoma ipofisario ACTH-secernente.

A.3.1

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

Italian study to evaluate the efficacy of retinoic acid and cabergoline therapy in combination in Cushing's disease.

Valutazione dell'efficacia della terapia con acido retinoico e cabergolina in combinazione nella malattia di Cushing.

A.3.2

Name or abbreviated title of the trial where available

CRACCA

A.4.1

Sponsor's protocol code number

CRACCA-2019

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	Dipartimento di Medicina-DIMED, università di Padova
B.1.3.4	Country	Italy
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	AIFA - Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dipartimento di Medicina-DIMED
B.5.2	Functional name of contact point	Segreteria Dipartimento di Medicina
B.5.3	Address:
B.5.3.1	Street Address	via Giustiniani 2
B.5.3.2	Town/ city	Padova
B.5.3.3	Post code	35128
B.5.3.4	Country	Italy
B.5.6	E-mail	dipartimento.medicinadimed@pec.unipd.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Dostinex
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Italia Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Cabergolina
D.3.2	Product code	[G02CB03]
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.3.8	INN - Proposed INN	CABERGOLINA
D.3.9.1	CAS number	81409-90-7
D.3.9.2	Current sponsor code	OPR000000310
D.3.9.3	Other descriptive name	NON COMMERCIAL
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	3500
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	VESANOID
D.2.1.1.2	Name of the Marketing Authorisation holder	Cheplapharm Arzneimittel Gmbh
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Tretinoina
D.3.2	Product code	[L01XX14]
D.3.4	Pharmaceutical form	Capsule, soft
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	TRETINOINA
D.3.9.1	CAS number	302-79-4
D.3.9.2	Current sponsor code	OPR000000310
D.3.9.3	Other descriptive name	NON COMMERCIAL
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	80
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

Cushing's disease in patients in whom pituitary surgery has not been curative or in situations where it is contraindicated or refused by patient.

Malattia di Cushing in pazienti in cui la chirurgia ipofisaria non sia stata curativa o nelle situazioni i cui sia controindicata o rifiutata dal paziente.

E.1.1.1

Medical condition in easily understood language

Cushing's disease

Malattia di Cushing

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10011651
E.1.2	Term	Cushing's disease
E.1.2	System Organ Class	100000004860

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the effectiveness of cabergoline (initial dosage of 1.5 mg/week) and retinoic acid (initial dosage of 20 mg/day) monotherapies after 3 months and their combination 6 months from baseline

Valutare l’efficacia della monoterapia con cabergolina (dosaggio iniziale di 1.5 mg/settimana) ed acido retinoico (dosaggio inziale di 20 mg/die), in monoterapia dopo 3 mesi di trattamento e della loro combinazione a 6 mesi dall’inizio dello studio

E.2.2

Secondary objectives of the trial

1. Evaluate the changes in urinary free cortisol with respect to baseline at each scheduled visit
2. Evaluate the effects on ACTH, serum cortisol and salivary in the two treatment groups compared to baseline
3. Assess the variation of continuous clinical variables in the two treatment arms compared to the baseline
4. To evaluate the effects on categorical clinical parameters in the two treatment groups at each visit
5. Evaluate the effects on quality of life in the two treatment groups
6. Evaluate the safety profile of each monotherapy treatment and their combination (CA + RA and RA + CA)

1. Valutare le variazioni di cortisolo libero urinario rispetto al baseline ad ogni visita programmata
2. Valutare gli effetti su ACTH, cortisolo sierico e salivare nei due gruppi di trattamento rispetto al baseline
3. Valutare la variazione delle variabili cliniche di tipo continuo nei due bracci di trattamento rispetto al baseline
4. Valutare gli effetti su parametri clinici di tipo categoriale nei due gruppi di trattamento ad ogni visita
5. Valutare gli effetti sulla qualità di vita nei due gruppi di trattamento
6. Valutare il profilo di sicurezza di ciascun trattamento in monoterapia e della loro combinazione (CA+RA e RA+CA)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age> 18 years at the enrollment visit
Diagnosis of Cushing's disease with at least one criterion between:
· Immunohistochemistry positive for ACTH of the pituitary adenoma
Center / periphery gradient> 3 for ACTH after CRH catheterization of the petrosal sinuses
· At least two positive tests between CRH response (ACTH> 50% from baseline), suppression of cortisol after high doses of dexamethasone (> 80% from baseline), pituitary MRI with adenoma = 6mm; remission of hypercorticism after pituitary surgery
. Biochemical hypercorticism before enrollment (mCLU> ULN)
. Adequate performance status: ECOG = 2
. Verbal and written informed consent of the patient before any screening procedure
· Patients who have already undergone transphenoidal surgery or patients who are not candidates for surgery
. Failure of medical treatments currently available for Cushing's disease (failure to normalize urinary free cortisol values after at least 3 months of treatment with the maximum tolerated dose of the drug and / or persistence of signs and symptoms related to hypercortisolism)
. Adequate contraception (see section 4.1.1)

· età > 18 anni alla visita di arruolamento
· Diagnosi di Malattia di Cushing con almeno un criterio tra:
· Immunoistochimica positiva per ACTH dell’adenoma ipofisario
· Gradiente centro/periferia >3 per ACTH dopo CRH al cateterismo dei seni petrosi
· Almeno due test positivi tra risposta al CRH (ACTH >50% rispetto al basale), soppressione del cortisolo dopo alte dosi di desametasone (>80% rispetto al basale), RMN ipofisi con adenoma =6mm; remissione dell’ipercorticismo dopo chirurgia ipofisaria
· Ipercorticismo biochimico prima dell’arruolamento (mCLU > ULN)
· Performance status adeguato: ECOG =2
· Consenso informato verbale e scritto del paziente prima di qualunque procedura di screening.
· Pazienti già sottoposti ad intervento chirurgico transfenoidale risultato non risolutivo o pazienti non candidabili a chirurgia
· Fallimento dei trattamenti medici attualmente disponibili per la malattia di Cushing (mancata normalizzazione dei valori di cortisolo libero urinario dopo almeno 3 mesi di trattamento con la massima dose di farmaco tollerata e/o persistenza di segni e sintomi riferibili ad ipercortisolismo)
· Adeguata contraccezione (vedi 4.1.1)

E.4

Principal exclusion criteria

- ACTH-independent Cushing's syndrome
- Pituitary surgery in the last 2 months prior to enrollment
- Radiotherapy in the previous 3 years
- Genetic-related causes of Cushing's syndrome (Carney complex, McCune-Albright syndrome, MEN-1)
- Major surgery in the month preceding the start of the study- Heart failure (NYHA class III or IV), unstable angina, severe arrhythmic syndrome, or clinically significant alteration of cardiovascular function
- Heart failure (NYHA class III or IV), unstable angina, severe arrhythmic syndrome, or clinically significant alteration of cardiovascular function
· Mitotane therapy in the year preceding the enrollment
- Hepatopathy, such as cirrhosis, chronic active hepatitis or chronic hepatitis, or AST / ALT levels> 2 x ULN, creatininemia> 2 x ULN, bilirubinemia> 2 x ULN
- White blood cell (WBCs) <3 x 109 / L; platelets <100 x 109 / L
- Any previous or current surgical or medical condition that may interfere with the conduct of the study or the evaluation of the results according to the Investigator's opinion
- Patients with ECG abnormalities or risk of torsades de pointes (correct QT> 470 mSec, hypokalemia, hypomagnesemia, family history of long QT syndrome)
- Pregnancy or lactation period
- Alcohol abuse or drug abuse
- Any other recent or active neoplastic disease (with the exception of cutaneous basal cancer and in situ carcinoma of the cervix or other malignant neoplasms without evidence of disease in the last 3 years)
- Acute infection or chronic uncontrolled infection
- Ongoing therapy with antifibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin
- Hypersensitivity to tretinoin or other retinoids, to cabergoline, ergot alkaloids, to soy, peanuts, fructose or to any of the excipients listed in section 6.1. of the RCP of the two IMPs
- History of pulmonary, pericardial or retroperitoneal fibrosis, evidence of cardiac valvulopathy determined on the echocardiogram performed before treatment
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Raynaud's syndrome
- History of peptic ulcer or previous gastrointestinal bleeding
- History of serious mental disorders (especially if psychotic)
- Patient judged to be potentially unreliable and/or uncooperative towards the procedures of the study or judged incapable of completing the entire study.

· Sindrome di Cushing ACTH-indipendente
· Chirurgia ipofisaria nei 2 mesi precedenti
· Radioterapia nei 3 anni precedenti
· Ipercortisolismo da Sindrome ereditaria (complesso di Carney, sindrome di McCune-Albright, MEN-1)
· Intervento chirurgico maggiore nel mese precedente l’inizio dello studio
· Scompenso cardiaco (classe NYHA III o IV), angina instabile, grave sindrome aritmica, o alterazione clinicamente significativa della funzione cardiovascolare
· Terapia con mitotane nell’anno precedente l’arruolamento
· Epatopatia, come cirrosi, epatite cronica attiva o epatite cronica persistente, o livelli di AST/ALT > 2 x ULN, creatininemia > 2 x ULN, bilirubinemia > 2 x ULN
· Conta dei GB < 3 x 109 /L; piastrine < 100 x 109 /L
· Qualsiasi condizione chirurgica o medica precedente o attuale che possa interferire con la condotta dello studio o con la valutazione dei risultati secondo l’opinione dello Sperimentatore
· Pazienti con alterazioni ECG o rischio di torsioni di punta (QT coretto >470 mSec, ipopotassemia, ipomagnesemia, storia familiare di sindrome del QT lungo)
· Pazienti in gravidanza o allattamento
· Abuso di alcol o abuso di farmaci
· Qualsiasi altra ulteriore patologia neoplastica recente o attiva (ad eccezione del basalioma cutaneo e del carcinoma in situ della cervice o altre neoplasie maligne senza evidenza di malattia negli ultimi 3 anni)
· Infezione acuta o cronica non controllata
· Terapia in atto con agenti antifibrinolitici, quali l’acido tranexamico, l’acido aminocaproico o l’aprotinina
· Ipersensibilità alla tretinoina o altri retinoidi, alla cabergolina, agli alcaloidi dell’ergot, alla soia, alle arachidi, al fruttosio o ad uno qualsiasi degli eccipienti elencati al paragrafo 6.1. del RCP dei due IMP
· Storia di fibrosi polmonare, pericardica o retroperitoneale, evidenza di valvulopatia cardiaca determinata all'ecocardiogramma eseguito prima del trattamento
· Problemi ereditari di intolleranza al galattosio, da deficit di Lapp lattasi o da malassorbimento di glucosio-galattosio,
· Sindrome di Raynaud,
· Storia di ulcera peptica o pregresse emorragie gastrointestinali
· Storia di gravi disturbi mentali (soprattutto se psicotici)
· Paziente giudicato potenzialmente inaffidabile e/o non collaborante nei confronti delle procedure dello studio o giudicato incapace di completare l’intero studio.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients that urinary free cortisol values (mean of two values) evaluated after 3 months of treatment for monotherapy, and after 6 months of treatment for combined therapy.

Proporzione di pazienti che normalizzano i valori di cortisolo libero urinario (media di due valori) valutati dopo 3 mesi di trattamento per la monoterapia e dopo 6 mesi di trattamento per la terapia combinata.

E.5.1.1

Timepoint(s) of evaluation of this end point

after 3 and 6 months of treatment

a 3 e 6 mesi di trattamento

E.5.2

Secondary end point(s)

1. Absolute and percentage change in the mean CLU value with respect to baseline at each visit
2. Absolute and percentage changes in ACTH, serum cortisol and salivary at each visit compared to the baseline
3. Absolute and percentage variations of clinical (blood pressure, body mass index, waist circumference) and biochemical (total cholesterol, HDL, LDL, triglycerides, blood sugar, HbA1c, insulin) variables
4. Variation of clinical signs with respect to baseline: rubeosis, hirsutism, strie rubrae, muscle atrophy, supraclavicular fat
5. Change in Cushing QoL questionnaire score after 3 and 6 months of treatment
6. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.5) and by performing blood and instrumental tests (blood count, kidney and liver function, lipid and glycemic profile, echocardiogram)

1. Variazione assoluta e percentuale della media del CLU rispetto al baseline ad ogni visita
2. Variazione assoluta e percentuale di ACTH, cortisolo sierico e salivare ad ogni visita rispetto al baseline
3. Variazione assoluta e percentuale delle variabili cliniche (pressione arteriosa, body mass index, waist circumference) e biochimiche (colesterolo totale, HDL, LDL, trigliceridi, glicemia, HbA1c, insulina)
4. Variazione rispetto al baseline dei segni clinici: rubeosi, irsutismo, strie rubrae, atrofia muscolare, grasso sovraclavicolare
5. Variazione rispetto al baseline del punteggio del questionario Cushing QoL dopo 3 e 6 mesi
6. La tossicità sarà valutata usando il National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.5) e tramite esecuzione di esami ematochimici e strumentali (emocromo, funzione renale ed epatica, profilo lipidico e glicemico, ecocardiogramma).

E.5.2.1

Timepoint(s) of evaluation of this end point

after 6 and 12 months of treatment

a 6 e 12 mesi di trattamento

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

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-10-07.

Yes

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

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)

Patients may refer to the local standard of care following the completion of this trial.

I pazienti potranno fa riferimento allo standard locale di assistenza a seguito del completamento di questa sperimentazione.

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

2020-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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