Clinical Trials Register

Summary
EudraCT Number:	2018-000572-15
Sponsor's Protocol Code Number:	GRASPANC2018-01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-29
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-000572-15

A.3

Full title of the trial

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma

Studio randomizzato di fase 3 su Eryaspase in combinazione con chemioterapia rispetto alla sola chemioterapia come trattamento di seconda linea in pazienti affetti da adenocarcinoma pancreatico. TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer (sperimentazione di eryaspase nel cancro del pancreas)

A.3.1

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

Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapy

Studio clinico in soggetti affetti da adenocarcinoma pancreatico per valutarela sicurezza e l'efficacia di un farmaco in studio (eryaspase) quando aggiunto alla chemioterapia standard

A.3.2

Name or abbreviated title of the trial where available

TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer

TRYbeCA-1 – sperimentazione di eryaspase nel cancro del pancreas)

A.4.1

Sponsor's protocol code number

GRASPANC2018-01

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	ERYTECH PHARMA S.A.
B.1.3.4	Country	France
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	ERYTECH Pharma
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ERYTECH PHARMA SA
B.5.2	Functional name of contact point	Iman El-Hariry
B.5.3	Address:
B.5.3.1	Street Address	AVENUE ROCKEFELLER 60
B.5.3.2	Town/ city	Lyon
B.5.3.3	Post code	69008
B.5.3.4	Country	France
B.5.4	Telephone number	0033478744438
B.5.5	Fax number	0033478755629
B.5.6	E-mail	vsemareg@erytech.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/3/09/633
D.3 Description of the IMP
D.3.1	Product name	Eryaspase
D.3.2	Product code	[0000]
D.3.4	Pharmaceutical form	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	L-ASPARAGINA MONOIDRATO
D.3.9.2	Current sponsor code	0000
D.3.9.4	EV Substance Code	SUB181586
D.3.10	Strength
D.3.10.1	Concentration unit	kunit kilo units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pancreatic Adenocarcinoma

Adenocarcinoma pancreatico

E.1.1.1

Medical condition in easily understood language

Pancreatic Adenocarcinoma

Adenocarcinoma pancreatico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10051971
E.1.2	Term	Pancreatic adenocarcinoma
E.1.2	System Organ Class	100000004864

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

The primary objective of this study is to determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in secondline treatment of pancreatic adenocarcinoma compared to chemotherapy alone.

Determinare se l'aggiunta di eryaspase alla chemioterapia migliori la sopravvivenza complessiva (OS, overall survival) nel trattamento di seconda linea dell'adenocarcinoma pancreatico rispetto alla sola chemioterapia.

E.2.2

Secondary objectives of the trial

To compare (PFS) between the 2 treatment arms. - To compare the (ORR) and (DoR) between the 2 treatment arms. -To compare the (DCR) between the 2 treatment arms. -To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone. - To assess the effect of eryaspase on quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ C30). -To determine the pharmacokinetics of eryaspase. To assess the immunogenicity of eryaspase in terms of the induction of anti-asparaginase antibodies and neutralizing antibodies. SEE PROTOCOL COMPLETE LIST

Confrontare la PFS tra i 2 bracci di tratt. - Confrontare l’ORR e la DoR tra i 2 gruppi di tratt. - Confrontare il tasso di controllo della malattia tra i 2 gruppi di tratt. - Valutare la sicurezza e la tollerabilità di eryaspase in comb. con chemioter rispetto alla sola chemioter -Valutare l’effetto di eryaspase sulla QOL utilizzando il questionario principale di mis. della qualità di vita redatto da (EORTC QLQ C30). -Stabilire la farmacocinetica di eryaspase. -Valutare l'immunogenicità di eryaspase in term di induzione di anticorpi anti-asparaginasi e di anticorpi neutralizzanti. PER LISTA COMPLETA FARE RIF AL PROTOCOLLO

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Must be 18 years of age or older.
2.Must have histologically confirmed pancreatic adenocarcinoma.
3.Must have Stage III or IV disease (see Appendix 1).
4.Must have received only one line of systemic chemotherapy in advanced setting with or without targeted agents, immunotherapy, or radiotherapy
for treatment of advanced pancreatic adenocarcinoma.
5.Must have radiological evidence of disease progression following most recent prior treatment, defined as appearance of any new
lesion or increase of >20% of one or more existing lesions.
6.Must have measurable lesion(s) per RECIST version 1.1 by CT scan with contrast (or MRI, if the patient is allergic to CT contrast media).
oMeasurable disease may be in the field of prior irradiation; however, at least 4 weeks must have elapsed between the completion of radiation therapy and the baseline scan documenting disease status.
oBone disease is considered radiologically measurable only if there is at least a 50% lytic component.
NOTE: Bone disease consisting of blastic lesion only is not measurable.
7.Archival or fresh tumor tissue must be available for evaluating relevant biomarkers. Formalin-fixed paraffin-embedded [FFPE] block preferred, or a minimum of 10 unstained FFPE slides of one archived block is required. NOTE: cytology samples from fine
needle aspirates or brushing biopsies are not sufficient.
8.Must have adequate performance status (see Appendix 2 and 3):
oECOG Performance Status (PS) score of 0, or
oECOG PS score 1 and score =80 on Karnofsky Performance Status (KPS) scale.
NOTE: Must have body mass index (BMI) =18.5 kg/m2 (obtained <14 days prior to randomization
9.Must have life expectancy of >12 weeks according to the Investigator’s clinical judgment.
10.Females of childbearing potential must have a negative pregnancy test at screening and additional pregnancy test prior to first dose. Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment
and for at least 6 months after the last dose of study treatment.These include, but not limited to:
a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i. intravaginal ii. transdermal
b. progestogen-only hormonal contraception associated with inhibition of ovulation: i. injectable ii. implantable
c. intrauterine device (IUD) d. bilateral tubal occlusion
e. vasectomised partner f. sexual abstinence (defined as refraining from heterosexual intercourse
during the entire period of risk associated with the study treatments) is intended. g. males with partners of childbearing potential must agree to use condoms
NOTE: Since an indirect interaction between components of the oral contraceptives and ASNase cannot be ruled out, oral contraceptives are
not considered acceptable as contraceptive methods in the current clinical trial. A method other than oral contraception should be used in women of childbearing potential. NOTE: All chemotherapeutic agents may be teratogenic and excreted in breast milk. Patients who are breast feeding should consider alternative
methods. Please refer to protocol for complete list

1. Deve aver compiuto i 18 anni di età.
2. Deve presentare adenocarcinoma del pancreas confermato istologicamente.
3. Deve presentare malattia di Stadio III o IV (vedere Appendice 1).
4. Deve aver ricevuto una sola linea di chemioterapia sistemica in setting avanzato con o senza farmaci target, immunoterapia o radioterapia per il trattamento dell'adenocarcinoma pancreatico avanzato.
5. Deve presentare evidenza radiologica di progressione della malattia dopo il trattamento precedente più recente, definita come la comparsa di qualsiasi nuova lesione o l'aumento di > 20% di una o più lesioni esistenti.
6. Deve presentare lesione/i misurabile/i secondo RECIST versione 1.1 mediante TAC con mezzo di contrasto (o RMI, se il paziente è allergico al mezzo di contrasto della TAC).
o La malattia misurabile può essere nel campo della precedente irradiazione; tuttavia, devono essere trascorse almeno 4 settimane tra il completamento della radioterapia e la scansione basale che documenta lo stato della malattia.
o La malattia ossea è considerata misurabile radiologicamente solo se è presente almeno un 50% di componente litica.
NOTA: la malattia ossea costituita solo da lesioni blastiche non è misurabile.
7. Deve essere disponibile tessuto tumorale d'archivio o recente per la valutazione dei biomarcatori rilevanti. Sono richiesti preferibilmente una porzione fissata con formalina e inclusa in paraffina [FFPE] oppure almeno 10 vetrini FFPE non colorati di una porzione d'archivio. NOTA: non sono sufficienti i campioni citologici da agobiopsia o spazzolato.
8. Deve presentare stato di performance adeguato (vedere Appendice 2 e 3):
o Punteggio dello stato di performance (PS) ECOG pari a 0, o
o Punteggio PS ECOG pari a 1 e punteggio = 80 sulla scala dello stato di performance di Karnofsky (KPS).
NOTA: Deve avere un indice di massa corporea (BMI) = 18,5 kg/m 2 (ottenuto <14 giorni prima della randomizzazione)
9. Deve avere un'aspettativa di vita di > 12 settimane secondo il giudizio clinico dello sperimentatore.
10. Le donne in età fertile devono risultare negative al test di gravidanza eseguito allo
screening a al test aggiuntivo negativo precedente la prima dose. I soggetti di sesso
maschile e femminile in età fertile devono accettare di utilizzare un metodo
contraccettivo altamente efficace durante il trattamento e per almeno 6 mesi dopo
l'ultima dose di trattamento in studio. Questi comprendono, a titolo esemplificativo ma
non esaustivo:
a) contraccettivo ormonale combinato (contenente estrogeni e progestinici) associato
a inibizione dell'ovulazione:
i. intravaginale
ii. transdermico
b. contraccezione ormonale basata solo su progestinici, associata a inibizione
dell'ovulazione:
i. iniettabile
ii. impiantabile
c) dispositivo intrauterino (IUD)
d) occlusione bilaterale delle tube
e) partner vasectomizzato
f) astinenza sessuale (definita come astensione da rapporti eterosessuali durante
l'intero periodo di rischio associato ai trattamenti in studio). L'astinenza totale è
accettabile quando ciò è in linea con lo stile di vita preferito e abituale del soggetto.
[L'astinenza periodica (come i metodi del calendario, dell’ovulazione, sintotermico,
post-ovulazione) e il coito interrotto non sono considerati metodi contraccettivi
accettabili].
g) I maschi con partner in età fertile devono accettare di usare il preservativo
NOTA: poiché un'interazione indiretta tra componenti dei contraccettivi orali e
asparaginasi non può essere esclusa, i contraccettivi orali non sono considerati
accettabili come metodi contraccettivi nella sperimentazione clinica attuale. Le donne
in età fertile devono utilizzare un metodo diverso dalla contraccezione orale.
NOTA: tutti gli agenti chemioterapici possono essere teratogeni ed escreti nel latte
materno. Le pazienti che allattano al seno dovranno prendere in considerazione
metodi alternativi
PER ELENCO COMPLETO FARE RIFERIMENTO AL PROTOCOLLO

E.4

Principal exclusion criteria

1.Resectable or borderline resectable pancreatic adenocarcinom at the time of signing theinformed consent.
2.Histology other than pancreatic adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous, etc.).
3.More than 1 line of prior treatment in advanced or metastatic setting.
4.Patient has experienced medically significant acute decline in clinical status including
a.Decline in ECOG PS to >1 (or KPS <70) between baseline visit and within 72 hours prior to randomization.
b.Weight loss of =10% during screening.
5.Presence of active or symptomatic untreated central nervous system (CNS) metastases.
NOTE: Patients with asymptomatic or stable CNS metastases are eligible, provided that the CNS metastases are radiologically and
clinically stable, and the patient is off high dose steroid treatment for at least 1 month prior to randomization.
6.Prior radiotherapy to the only area of measurable disease,
NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of
the first dose of eryaspase or chemotherapy.
7.Bone as the only site of metastatic disease from pancreatic cancer (bone-only disease).
8.History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
NOTE: The revised Atlanta classification [1] requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level =3 x ULN, or (c) characteristic imaging findings using CT or MRI.
9ase including symptomatic congestive

1. Adenocarcinoma pancreatico resecabile o resecabile borderline al momento della firma del consenso informato
2. Esame istologico con esito diverso da adenocarcinoma del pancreas (a titolo di esempio: neuroendocrino, adenosquamoso).
3. Più di 1 precedente linea di trattamento nel contesto avanzato o metastatico.
4. Il paziente ha manifestato un declino acuto dello stato clinico significativo sotto il profilo medico, tra cui
a. Riduzione del PS ECOG a >1 (o KPS <70) tra la visita basale e le 72 ore precedenti la randomizzazione.
b. Perdita di peso =10% durante lo screening.
5. Presenza di metastasi del sistema nervoso centrale (SNC) non trattate attive o sintomatiche.
NOTA: i pazienti con metastasi del SNC asintomatiche o stabili sono eleggibili, a condizione che le metastasi del SNC siano radiologicamente e clinicamente stabili e che il paziente non abbia assunto steroidi a dosaggio elevato per almeno 1 mese prima della randomizzazione.
6. Precedente radioterapia localizzata alla sola area di malattia misurabile,
NOTA: i pazienti devono avere completato il trattamento ed essersi ristabiliti da tutte le tossicità acute correlate al trattamento prima della somministrazione della prima dose di eryaspase o chemioterapia.
7. Ossa come unica sede di malattia metastatica da cancro del pancreas (malattia limitata alle ossa).
8. Anamnesi di pancreatite clinica recente, in base ai criteri di Atlanta rivisti, nei 3 mesi precedenti la randomizzazione.
NOTA: la classificazione di Atlanta rivista [1] richiede che siano soddisfatti due o più dei seguenti criteri per la diagnosi di pancreatite acuta: (a) dolore addominale che suggerisce presenza di pancreatite, (b) livello di amilasi o lipasi nel siero =3 x ULN o (c) risultati caratteristici negli esami di imaging eseguiti mediante TAC o RMI.

E.5 End points

E.5.1

Primary end point(s)

to determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in secondline treatment of pancreatic adenocarcinoma compared to chemotherapy alone.

E.5.1.1

Timepoint(s) of evaluation of this end point

To be measured from the date of randomization to the date of death from any cause. Patients who are not known to have died will be censored at the date of last contact, and this will apply as of the date of data cut-off for any particular analysis.

Da misurare a partire dalla data della randomizzazione fino alla data del decesso per qualsiasi causa. I pazienti dei quali non è noto il decesso saranno censurati alla data dell'ultima contatto, e ciò si applicherà a partire dalla data di cut-off dei dati per qualsiasi particolare analisi

E.5.2

Secondary end point(s)

To compare progression-free survival (PFS) between the 2 treatment arms; To compare the objective response rate (ORR) and duration of response (DoR) between the 2 treatment arms.; To compare the disease control rate (DCR) between the 2 treatment arms; • To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone.; To assess the effect of eryaspase on quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC
QLQ-C30).; To determine the pharmacokinetics of eryaspase.

•Confrontare la sopravvivenza libera da progressione (PFS, progression-free survival) tra i 2 bracci di trattamento.; •Confrontare il tasso di risposta obiettiva (ORR, objective response rate) e la durata della risposta (DoR, duration of response) tra i 2 gruppi di trattamento.; Confrontare il tasso di controllo della malattia (DCR, disease control rate) tra i 2 gruppi di trattamento.; Valutare la sicurezza e la tollerabilità di eryaspase in combinazione con chemioterapia rispetto alla sola chemioterapia.; Valutare l’effetto di eryaspase sulla qualità di vita utilizzando il questionario principale di misurazione della qualità di vita redatto dall'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC QLQ C30).; Determinare la farmacocinetica di eryaspase

E.5.2.1

Timepoint(s) of evaluation of this end point

PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same; PFS will be compared between the 2 treatment arms using the same

La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS.; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analis

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessuno

no comparator

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

United States

Austria

Belgium

Czechia

Denmark

Finland

France

Germany

Netherlands

Spain

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

Last PatientLast Visit

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:

338

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

144

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

416

F.4.2.2

In the whole clinical trial

482

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)

none

nessuno

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

2018-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-20

P. End of Trial
P.	End of Trial Status	Completed

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