Clinical Trials Register

Summary
EudraCT Number:	2018-001344-57
Sponsor's Protocol Code Number:	PENTALLO
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:	2021-06-17
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

2018-001344-57

A.3

Full title of the trial

Pentaglobin as early adjuvant treatment for febrile neutropenia in acute leukemia or allogeneic hematopoietic stem cell transplant patients colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa

Pentaglobin come trattamento adiuvante della neutropenia febbrile in pazienti affetti da leucemia acuta o candidati a trapianto allogenico di cellule staminali emopoietiche e colonizzati da Enterobatteri resistenti ai carbapenemici o da Pseudomonas aeruginosa

A.3.1

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

Penataglobin profilaxis in patients with acute leukemia or candidate to allogeneic transplant colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa

Profilassi con Pentaglobin nelle leucemie acute o pazienti candidati a trapianto allogenico e colonizzati da Enterobatteri resistenti ai carbapenemici o da Pseudomonas aeruginosa

A.3.2

Name or abbreviated title of the trial where available

PENTALLO

A.4.1

Sponsor's protocol code number

PENTALLO

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03494959

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	GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA
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	Biotest AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GITMO
B.5.2	Functional name of contact point	Trial Office
B.5.3	Address:
B.5.3.1	Street Address	C/O AOU IRCCS SAN MARTINO-IST PAD. 6 TERRA LARGO ROSANNA BENZI 10
B.5.3.2	Town/ city	Genova
B.5.3.3	Post code	16132
B.5.3.4	Country	Italy
B.5.4	Telephone number	0105554423
B.5.5	Fax number	010515491
B.5.6	E-mail	sonia.mammoliti@hsanmartino.it

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	PENTAGLOBIN - 50 MG/ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOTEST PHARMA 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	Pentaglobin
D.3.2	Product code	[Pentaglobin]
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.3.9.2	Current sponsor code	Pentaglobin
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	50
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	Yes
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	PENTAGLOBIN - 50 MG/ML SOLUZIONE PER INFUSIONE 1 FLACONE DA 50 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOTEST PHARMA 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	Pentaglobin
D.3.2	Product code	[Pentaglobin]
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.3.9.2	Current sponsor code	Pentaglobin
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	50
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	Yes
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: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PENTAGLOBIN - 50 MG/ML SOLUZIONE PER IINFUSIONE 1 FLACONE DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOTEST PHARMA 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	Pentaglobin
D.3.2	Product code	[Pentaglobin]
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.3.9.2	Current sponsor code	Pentaglobin
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	50
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	Yes
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

The study will enroll consecutive adult patients suffering from acute leukemia candidate to intensive chemotherapy or patients with hematological cancers candidate to allogeneic transplant with a documented colonization sustained by Carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa.

Pazienti adulti affetti da leucemia acuta e candidati a chemioterapia intensiva o pazienti con malattie ematologiche con indicazione a trapianto allogenico con documentata una colonizzazione da Enterobatteriaceae resistenti ai carbapenemi o da Pseudomonas aeruginosa.

E.1.1.1

Medical condition in easily understood language

Patients with acute leukemia or candidate to allogeneic transplant for hematological disease with Gram-negative infection antibiotic-resistant

Pazienti con leucemia acuta o pazienti candidati al trapianto di midollo per malattia ematologica portatori di germi Gram-negativi resistenti agli antibiotici

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

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	10013120
E.1.2	Term	Diseases of blood and blood-forming organs, unspecified
E.1.2	System Organ Class	100000004851

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 demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae (CRE) or by any Pseudomonas aeruginosa (PA).

Dimostrare che una terapia adiuvante precoce con Pentaglobin, all’esordio della neutropenia febbrile, in associazione alla miglior terapia antibiotica disponibile è in grado di ridurre la mortalità da sepsi sostenuta da Enterobatteri resistenti ai carbapenemici (CRE) o Pseudomonas aeruginosa (PA) e migliorare la sopravvivenza globale di pazienti affetti da leucemie acute o candidati a trapianto allogenico che risultano portatori di tali patogeni pretrattamento

E.2.2

Secondary objectives of the trial

- To evaluate the overall impact of Pentaglobin administration in the study population concerning: adverse drug reactions, infectious complications and treatment-related mortality.
- Incidence and severity of acute and chronic GvHD.
- Incidence of graft failure / time to neutrophil and platelet recovery.
- Probability of GRFS (GvHD free, relapse free survival).

- Valutare l’impatto globale dell’impiego di Pentaglobin sulla popolazione in studio riguardo ad: eventi aversi e reazioni al farmaco, complicanze infettive e alla mortalità legata al trattamento chemioterapico/trapiantologico
- Incidenza e severità della GVHD acuta e cronica
- Incidenza del fallimento dell’attecchimento e tempo di ricostituzione di neutrofili e piastrine
- Probabilità di GRFS (assenza di GvHD, sopravvivenza libera da malattia).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age > or = 18 years
• Performance status: ECOG <3
• Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy or Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed)
• Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab or pre-treatment bloodstream infection sustained by CRE or PA
• Written and signed informed consent
• Patients participating in other clinical studies for allogeneic HSCT are also eligible to this study if the above-mentioned trials are using an approved investigational compound
• Possibility of starting treatment with Pentaglobin <12 hours after development of fever
• Treatment with other immunoglobulins (e.g. IVIG, Cytotect) should be not administered during the time of treatment with Pentaglobin.

• Età > = 18 anni
• Performance status: ECOG <3
• Diagnosi di leucemia mieloide acuta o leucemia linfoblastica acuta con indicazione a chemioterapia intensive oppure indicazione a trapianto allogenico di cellule staminali emopoietiche per neoplasie ematologiche, inclusi pazienti con diagnosi di anemia aplastica severa (secondi trapianti sono consentiti)
• Colonizzazione pre-trattamento da parte Enterobatteriaceae resistenti ai carbapenemici (CRE) o Pseudomonas aeruginosa (PA) e documentata tramite tampone rettale e/o faringeo oppure batteremia documentata pre-trattamento sostenuta da CRE or PA
• Consenso informato firmato
• Possono essere arruolati anche pazienti che partecipano ad altri studi clinici sottoposti a HSCT allogenico se gli studi sopra menzionati utilizzano un composto sperimentale approvato.
• Possibilità di iniziare il trattamento con Pentaglobina <12 ore dopo lo sviluppo della febbre
• Il trattamento con altre immunoglobuline (ad es. IVIG, Cytotect) non deve essere somministrato durante il periodo di trattamento con Pentaglobin.

E.4

Principal exclusion criteria

• Uncontrolled systemic infection
• -Hypersensitivity to the active substance or to any of the excipients of Pentaglobin
• Patients with previous anaphylaxis or severe reactions to immunoglobulins preparation
• Severe concomitant illness:
o patients with severe renal impairment
o patients with severe pulmonary impairment
o patients with severe cardiac impairment
o patients with severe hepatic impairment
• patients who on the basis of the investigator's consideration are not able to give the informed consent.

• Infezione sistemica non controllata
• Pazienti con pregresse anafilassi o reazioni gravi a preparati a base di immunoglobuline
• Allergia e/o intolleranza alle sostanze attive o agli eccipienti contenuti nel Pentaglobin
• Comorbidità clinicamente significative in particolare:
o Severa insufficienza renale
o Severa insufficienza polmonare
o Severa insufficienza cardiaca
o Severa insufficienza epatica
• Pazienti che a giudizio degli sperimentatori non sono in grado di fornire il consenso informato.

E.5 End points

E.5.1

Primary end point(s)

To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA)

Dimostrare una riduzione della mortalità sepsi-relata del 50% al giorno +30 dall’esordio nella neutropenia febbrile nei portatori di Enterobatteriaceae resistenti ai carbapenemici (CRE) o Pseudomonas aeruginosa (PA)

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days from pre-engraftment bloodstream infection

30 giorni dall’esordio nella neutropenia febbrile

E.5.2

Secondary end point(s)

To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls; Survival; Days of fever > 38.3°C; Days of hospitalization; Days of i.v. antimicrobials; Non-relapse mortality (NRM); Incidence and severity of adverse drug reactions (ADR) classified by System Organ Class (SOC) and preferred term (PT); Incidence and severity of acute GvHD; Incidence and severity of chronic GvHD; The cumulative incidence of graft failure / time to neutrophil and platelet recovery; GRFS (GvHD free, relapse free survival)

Migliorare del 20% la sopravvivenza globale a 4 mesi dall’inizio del trattamento intensivo in tutti i pazienti colonizzati da CRE o PA; Sopravvivenza; Giorni di febbre >38.3°C; Giorni di ricovero ospedaliero; Giorni di terapia antimicrobica; Mortalità non legata alla recidiva/progressione di malattia (NRM); Incidenza e severità delle reazioni al farmaco (ADR) classificate secondo il System Organ Class (SOC) e Termini (PT); Incidenza e severità della GvHD acuta; Incidenza e severità della GvHD cronica; Incidenza cumulativa del fallimento della ricostituzione ematologica e tempi di ricostituzione di neutrofili e piastrine; Probabilità di GRFS (GvHD free, relapse free survival)

E.5.2.1

Timepoint(s) of evaluation of this end point

4 months from the start of treatment; At 4 months from the start of intensive chemotherapy or transplant; 30 days from the day of start intensive chemotherapy or from day of transplant; 30 days from the start of intensive chemotherapy or transplant; 30 days from the start of intensive chemotherapy or transplant; 4 months from the start of intensive chemotherapy or transplant; 30 days from the start of treatment; 120 days form transplant; 1 year from transplant; at 30 and 60 days from the start of intensive chemotherapy or transplant; 1 year from the start of intensive chemotherapy or transplant

4 mesi dall’inizio del trattamento; 4 mesi dall’inizio della chemioterapia intensiva o dal trapianto; 30 giorni successivi all’inizio della chemioterapia intensiva (primo giorno di chemioterapia) o dal giorno del trapianto; 30 giorni dall’inizio della chemioterapia intensive o trapianto; 30 giorni dall’inizio della chemioterapia intensive o trapianto; 4 mesi dall’inizio della chemioterapia intensiva o trapianto.; 30 giorni dall'inizio del trattamento; 120 giorni dal trapianto; 1 anno dal trapianto; 30 e 60 giorni dall’inizio della chemioterapia intensiva o trapianto; 1 anno dall’inizio della chemioterapia intensiva o trapianto

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

E.6.5

Efficacy

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

E.8.1.1

Randomised

E.8.1.2

Open

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

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

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:

110

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

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

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

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)

None

Nessuno

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	Fondazione GIMEMA – Franco Mandelli Onlus
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-10

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

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IMP with orphan designation in the indication
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