Clinical Trials Register

Summary
EudraCT Number:	2018-000241-39
Sponsor's Protocol Code Number:	ID-054-304
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:	2021-02-02
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

2018-000241-39

A.3

Full title of the trial

A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH)

Studio prospettico, multicentrico, doppio cieco, randomizzato, a gruppi paralleli, di Fase 3 per valutare l'efficacia e la sicurezza di clazosentan nella prevenzione del deterioramento clinico dopo ischemia cerebrate ritardata (DCI), in soggetti adulti con emorragia da aneurisma subaracnoideo (aSAH).

A.3.1

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

Clinical research study with clazosentan to evaluate its effects on preventing complications due to the narrowing of the blood vessels (vasospasm) in the brain, caused by bleeding onto the surface of the brain.

Studio di ricerca clinica con clazosentan per valutare i suoi effetti nella prevenzione delle complicazioni dovute ad un restringimento dei vasi ematici cerebrali (vasospasmo), causato da un sanguinamento sulla superficie del cervello.

A.3.2

Name or abbreviated title of the trial where available

REACT study

Studio REACT

A.4.1

Sponsor's protocol code number

ID-054-304

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03585270

A.5.4

Other Identifiers

Name:

ID-054-304

Number:

ID-054-304

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	IDORSIA PHARMACEUTICALS LTD
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Idorsia Pharmaceuticals Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Idorsia Pharmaceuticals Ltd
B.5.2	Functional name of contact point	Clinical Trial Disclosure Desk
B.5.3	Address:
B.5.3.1	Street Address	Hegenheimermattweg 91
B.5.3.2	Town/ city	Allschwil
B.5.3.3	Post code	4123
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041588441977
B.5.5	Fax number	0041588440108
B.5.6	E-mail	clinical-trials-disclosure@idorsia.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/03/182
D.3 Description of the IMP
D.3.1	Product name	Clazosentan
D.3.2	Product code	[ACT-108475]
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	Clazosentan
D.3.9.1	CAS number	180384-56-9
D.3.9.2	Current sponsor code	ACT-108475
D.3.9.4	EV Substance Code	SUB25412
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	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	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Aneurysmal Subarachnoid Hemorrhage

Emorragia da aneurisma subaracnoideo

E.1.1.1

Medical condition in easily understood language

When a brain aneurysm (bulge) ruptures, it causes bleeding into the compartment surrounding the brain, the subarachnoid space and is therefore also known as aneurysmal subarachnoid hemorrhage (aSAH).

Quando un aneurisma cerebrale si rompe, provoca un sanguinamento degli spazi circostanti il cervello, lo spazio subaracnoidale ed è pertanto noto come emorragia da aneurisma subaracnoidale(aSAH).

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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	10042316
E.1.2	Term	Subarachnoid haemorrhage
E.1.2	System Organ Class	10029205 - Nervous system disorders

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	10039330
E.1.2	Term	Ruptured cerebral aneurysm
E.1.2	System Organ Class	10029205 - Nervous system 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 efficacy of clazosentan in preventing clinical deterioration due to DCI, in subjects with aSAH.

Determinare l'efficacia di clazosentan nella prevenzione del deterioramento clinico da DCI in soggetti con aSAH.

E.2.2

Secondary objectives of the trial

To evaluate the effect of clazosentan on the incidence of all-cause new or worsened cerebral infarction = 5 cm3 in total volume at Day 16 poststudy drug initiation; to evaluate the effect of clazosentan on long-term clinical outcome,
cognition, and health-related quality of life (QoL) at Week 12 and QoL at Week 24 post-aSAH; to evaluate the safety and tolerability of clazosentan in the selected population up to 24 hours post-study drug discontinuation.

Valutare gli effetti di clazosentan nell'incidenza di infarti cerebrali, nuovi o in pprogression, di ogni caua = 5 cm3 come volume totale al Giorno 16 dopo l'inizio del trattamento; valutare gli effetti di clazosentan sulla progressione clinica a lungo termine, sulle funzioni cognitive, e sulla qualità della vita (QoL) a 12 e a 24 settimane dopo l'aSAH; valutare la sicurezza e la tollerabilità di clazosentan nella popolazione selezionata fino a 24 ore dopo la discontinuazione del trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent to participate in the study must be obtained from the subject or proxy/legal representative at any time from hospital admission to prior to initiation of any study-mandated procedure
2. Males and females aged 18 to 70 years (inclusive, at hospital admission).
3. Subjects with a ruptured saccular aneurysm, angiographically confirmed by DSA or CTA, which has been successfully secured within 72
hours of rupture, by surgical clipping or endovascular coiling
4. WFNS (World Federation of Neurosurgical Societies) grades 1–4 (based on Glasgow Coma Scale [GCS]) assessed after recovery from the
aneurysm-securing procedure and after external ventricular drainage for hydrocephalus, if required
5. Subjects must meet one of the two following inclusion criteria:
A) High-risk prevention: Subjects with a "thick and diffuse clot" (thick and diffuse is defined as a thick confluent clot, more than 4 mm in thickness, involving 3 or more basal cisterns) on the hospital admission CT scan, absence of cerebral vasospasm at the time of randomization, and possibility to start study drug in the ICU (or equivalent environment
where all protocol assessments can be performed and the Patient Management Guidelines followed), within 96 hours after the time of the aneurysm rupture.
OR
B) Early treatment: Subjects without a thick and diffuse clot on the hospital admission CT scan who develop asymptomatic or minimally symptomatic moderate to severe angiographic vasospasm, within the 14-day period post-aneurysm rupture, and for whom it is possible to start study drug in the ICU (or equivalent environment where all protocol assessments can be performed and the Patient Management Guidelines followed), within 24 hours of this angiographic diagnosis.
6. A) Presence of a cerebral CT scan, performed at least 8 hours postaneurysm-securing procedure and within 24 hours prior to randomization,
B) Absence of a significant (e.g., symptomatic) new or
worsened cerebral infarct or re-bleeding of the repaired aneurysm on the post-procedure CT scan.
7. A woman of childbearing potential is eligible only if the pregnancy test performed during the screening period is negative.

1. Il consenso informato scritto per partecipare allo studio deve essere ottenuto dal soggetto o dal delegato/rappresentante legale in qualsiasi momento dal ricovero ospedaliero prima dell'inizio di qualsiasi procedura di studio.
2. Maschi e femmine di età compresa tra 18 e 70 anni (inclusi, all’ammissione in ospedale).
3. Soggetti con aneurisma sacciforme fratturato, confermati angiograficamente mediante angiogramma di sottrazione digitale (DSA) o angiogramma con tomografia computerizzata (CTA), che è stato trattato con successo entro 72 ore dalla rottura, mediante procedura chirurgica o avvolgimento endovascolare.
4. Gradi WFNS 1-4 (basati sulla scala Glasgow Coma Scale [GCS]) valutati dopo il recupero dalla procedura di riparazione dell'aneurisma e dopo il drenaggio ventricolare esterno per idrocefalo, se necessario.
5. I soggetti devono soddisfare uno dei due seguenti criteri di inclusione:
A) Prevenzione ad alto rischio: soggetti con "coaguli spessi e diffusi" sulla tomografia computerizzata all’ammissione ospedaliera (TAC), assenza di vasospasmo cerebrale al momento della randomizzazione e possibilità di iniziare il farmaco sperimentale nell’unità di terapia intensiva (ICU o ambiente equivalente in cui è possibile eseguire tutte le valutazioni del protocollo e seguire le linee guida per la gestione del paziente) entro 96 ore dal momento della rottura dell'aneurisma.
O
B) Trattamento precoce: soggetti senza "coaguli spessi e diffusi" sulla TAC all’ammissione ospedaliera che sviluppano un vasospasmo angiografico moderato o severo asintomatico o minimamente sintomatico entro un intervallo di 14 giorni dalla rottura dell’aneurisma e per i quali è possibile iniziare il farmaco sperimentale in un’unità di terapia intensiva (o ambiente equivalente in cui è possibile eseguire tutte le valutazioni del protocollo e seguire le linee guida per la gestione del paziente) entro 24 ore dalla diagnosi angiografica.
6. A) Presenza di una TAC cerebrale, eseguita almeno 8 ore dopo l'aneurisma e 24 ore prima della randomizzazione,
B) Assenza dell’insorgenza di un nuovo e significativo (o sintomatico) infarto cerebrale o un suo aggravamento o un nuovo sanguinamento dell’aneurisma riparato nella TAC post-procedura.
7. Una donna in età fertile [vedere la definizione nella sezione 4.5] è eleggibile solo se il test di gravidanza del siero eseguito durante il periodo di screening è negativo.

E.4

Principal exclusion criteria

1. Subjects with SAH due to causes other than a saccular aneurysm (e.g., trauma or rupture of fusiform or mycotic aneurysms, SAH associated
with arterio-venous malformation, vertebral dissections).
2. Significant bleeding post aneurysm-securing procedure (e.g., due to intra-ventricular drain, intra-cerebral hemorrhage, epidural hematoma,
vessel dissection or rupture, re-bleeding of the repaired aneurysm), based on investigator judgment.
3. Intra-or peri-aneurysm securing procedure complication requiring non-routine medical or interventional treatment such as administration
of an antithrombotic or anti-platelet agent (e.g., abciximab), which is not completely resolved prior to randomization.
4. Intraventricular hemorrhage on the hospital admission CT scan, filling more than 50% of both lateral ventricles and with involvement of the
3rd and 4th ventricles.
5. Intracerebral hemorrhage on the hospital admission CT scan, with an approximate volume of > 50 mL.
6. Presence of cerebral vasospasm at hospital admission (initial admission or transfer from another hospital) believed to be associated with a prior bleed (i.e., occurring before the bleed for which the subject
is currently hospitalized). Vasospasm occurring during the aneurysm securing procedure is not an exclusion criterion.
Neurological and functional status:
7. Subjects with a new major neurological deficit occurring post aneurysm-securing procedure which is attributable to the procedure and does not improve to pre-procedure status before randomization.
8. Subjects with a GCS score of = 9 at the time of randomization and without intracranial pressure (ICP) monitoring.
9. modified Rankin Score of 3 or higher, prior to the aSAH (i.e., due to a chronic condition).
Other clinical considerations:
10. Subjects with total bilirubin > 2 times the upper limit of normal, and/or a known diagnosis or clinical suspicion of liver cirrhosis or moderate to severe hepatic impairment
11. Hypotension (systolic blood pressure [SBP] = 90 mmHg) at time of randomization that is refractory to treatment.
12. Unresolved pulmonary edema or significant pneumonia still present at the time of randomization, or severe hypoxia at the time of randomization in intubated subjects, defined as PaO2/FiO2 = 200.
13. High sustained ICP (> 25 mmHg lasting > 20 minutes) at time of randomization, despite optimal treatment, in subjects with ICP monitoring.
14. Severe cardiac failure requiring inotropic support at the time of randomization.

1. Soggetti con emorragia subaracnoidea (SAH) per motivi diversi da un aneurisma sacculare (ad es. trauma o rottura di aneurismi fusiformi o micotici, SAH associata a malformazione artero-venosa, dissezione vertebrale).
2. Sanguinamento significativo dopo procedura di riparazione dell'aneurisma (ad esempio, a causa di drenaggio intraventricolare, emorragia intra-cerebrale, ematoma epidurale, dissezione o rottura del vaso, nuova emorragia dell'aneurisma riparato *), sulla base del giudizio dello sperimentatore.
3. Complicanza durante procedura di riparazione intraoperatoria o peri-aneurisma che richiede un trattamento medico o interventistico non di routine come la somministrazione di un agente antitrombotico o anti-piastrinico (ad es. Abciximab), che non è completamente risolta prima della randomizzazione.
4. Emorragia intra-ventricolare alla TAC d’ammissione ospedaliera, che riempie più del 50% di entrambi i ventricoli laterali e con coinvolgimento del 3 ° e del 4 ° ventricolo.
5. Emorragia intra-cerebrale alla TAC d’ammissione ospedaliera, con un volume approssimativo > 50 ml.
6. Presenza di vasospasmo cerebrale all’ammissione ospedaliera (ricovero iniziale o trasferimento da un altro ospedale) che si ritiene associato ad un precedente sanguinamento (cioè, che si è verificato prima del sanguinamento per il quale il soggetto è attualmente ricoverato). Il vasospasmo che si verifica durante la procedura di riparazione dell'aneurisma non è un criterio di esclusione.
Stato neurologico e funzionale:
7. Soggetti con un nuovo grave deficit neurologico che si verifica dopo la procedura di riparazione dell'aneurisma che è attribuibile alla procedura e non migliora allo stato pre-procedura prima della randomizzazione.
8. Soggetti con un punteggio GCS = 9 al momento della randomizzazione e senza monitoraggio della pressione intracranica (ICP).
9. punteggio alla scala Rankin (MRS) modificata di 3 o superiore, precedentemente all'episodio di aSAH (cioè a causa di una condizione cronica).
Altre considerazioni cliniche:
10. Soggetti con bilirubina totale> 2 volte il limite superiore della norma e/o una diagnosi nota o sospetto clinico di cirrosi epatica o compromissione epatica da moderata a severa.
11. Ipotensione (pressione arteriosa sistolica = 90 mmHg) al momento della randomizzazione, refrattaria a trattamenti.
12. Edema polmonare non risolto o polmonite significativa ancora presente al momento della randomizzazione o grave ipossia al momento della randomizzazione in soggetti intubati, definita come PaO2/FiO2 = 200.
13. ICP sostenuta elevata (> 25 mmHg di durata> 20 minuti) al momento della randomizzazione, nonostante il trattamento ottimale, in soggetti con monitoraggio ICP.
14. Grave insufficienza cardiaca che richiede supporto inotropo al momento della randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

Occurrence of clinical deterioration due to DCI from study drug initiation up to 14 days post-study drug initiation.

Iinsorgenza di deterioramento clinico dovuto a ischemia cerebrale ritardata dall’introduzione del farmaco sperimentale fino a 14 giorni dopo l’introduzione del medesimo.

E.5.1.1

Timepoint(s) of evaluation of this end point

From study drug initiation up to 14 days post-study drug initiation.

Dall'inizio del trattament fino a 14 giorni dopo l'introduzione del medesimo.

E.5.2

Secondary end point(s)

1 - Main secondary endpoint: occurrence of all-cause new or worsened cerebral infarction = 5 cm3
(total volume) at Day 16 post study drug initiation
2 - Other secondary endpoint: Long-term clinical outcome assessed by the Glasgow Outcome Scale
Extended (GOSE) at Week 12 post-aSAH, dichotomized as follows: poor outcome (score = 4) and good outcome (score > 4).

1 - Principale endpoint secondario: insorgenza indipendentemente dalla causa di un nuovo infarto cerebrale o un suo aggramento, = 5 cm3 (volume totale) al giorno 16 dall'introduzione del farmaco in studio. 2 - Altro endpoint secondario: esito clinico a lungo termine valutato dalla scala Glasgow Outcome Extended (GOSE) alla settimana 12 post-aSAH, dicotomizzato in esito sfavorevole (punteggio = 4) ed esito favorevole (punteggio> 4).

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - At Day 16 post study drug initiation; 2 - At Week 12 post-aSAH.

1 - Al Giorno 16 dopo l'inizio del trattamento; 2 - Alla settimana 12 dopo aSAH.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

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

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of life; biomarkers.

Qualità della vita; biomarcatori.

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

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

Canada

Israel

Korea, Republic of

United States

Austria

Belgium

Czechia

Denmark

Finland

France

Germany

Hungary

Italy

Poland

Spain

Sweden

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

End of the trial is defined as last subject last visit (LSLV)

La conclusione dello studio è definita dall'ultima visita dell'ultimo paziente (LSLV)

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:

250

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Written inform consent must be obtained from the subject or proxy/legal representative, according to local regulations.

Il consenso informato scritto sarà ottenuto dal soggetto o dal tutore / rappresentante legale, secondo le normalite locali.

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

264

F.4.2.2

In the whole clinical trial

400

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)

After the participation into the trial, the subjects will be treated with the most appropriate therapy according to the investigator's judgment.

Dopo la partecipazione allo studio, i soggetti saranno trattati con la terapia che lo sperimentatore riterrà più opportuna.

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

2018-07-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-13

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

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