Clinical Trials Register

Summary
EudraCT Number:	2019-003901-93
Sponsor's Protocol Code Number:	RC2019.1.6_GIAQUINTO
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:	2021-01-21
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

2019-003901-93

A.3

Full title of the trial

Monocentric, indipendent, phase II clinical trial, randomized in open to three different lZ delivery sequences in pediatric patients aged 1 and 12, in intensive care and mechanically ventilated.

Trial clinico monocentrico, no profit, di fase II, randomizzato in aperto a tre diverse sequenze di somministrazione di LZ in pazienti pediatrici di età =1 e <12 anni, ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.

A.3.1

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

Sedation with lorazepam in intravenous administration during mechanical ventilation in paediatric intensive care

Sedazione con lorazepam in somministrazione endovenosa durante ventilazione meccanica in terapia intensiva pediatrica

A.3.2

Name or abbreviated title of the trial where available

LZ in paediatric intensive care

LZ in terapia intensiva pediatrica

A.4.1

Sponsor's protocol code number

RC2019.1.6_GIAQUINTO

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	IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
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	Ministero della salute finanziamento Ricerca Corrente
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	IRCCS, OSPEDALE PEDIATRICO BAMINO GESù
B.5.2	Functional name of contact point	SEGRETERIA TECNICO SCIENTIFICA DEL
B.5.3	Address:
B.5.3.1	Street Address	VIALE DI VILLA PAMPHILI 100
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00165
B.5.3.4	Country	Italy
B.5.4	Telephone number	0668592572
B.5.6	E-mail	chiara.mennini@opbg.net

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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Solution for injection
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	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Solution for injection
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	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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: 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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
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	TAVOR - 4 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Solution for injection
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	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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

Critical patients subjected to mechanical ventilation and hospitalized in PICU

Pazienti critici sottoposti a ventilazione meccanica e ricoverati in PICU

E.1.1.1

Medical condition in easily understood language

critically ill patients admitted to the DEA Red Area

pazienti critici, ricoverati in Area Rossa del DEA

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10038738
E.1.2	Term	Respiratory, thoracic and mediastinal disorders
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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

characterize the pharmacokinetic (PK) profiles of LZ administered in a bolus sequence - continuous infusion, as a sedative in pediatric patients aged =1 and <12 years, admitted to intensive care and subjected to mechanical ventilation.

caratterizzare i profili di farmacocinetica (PK) del LZ somministrato in sequenza boli - infusione continua, come sedativo in pazienti pediatrici di età =1 e <12 anni, ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.

E.2.2

Secondary objectives of the trial

• Evaluate the clinical safety of LZ in patients admitted to intensive care and subjected to mechanical ventilation.
• Evaluate the clinical response to LZ in patients admitted to intensive care and subjected to mechanical ventilation.
• To characterize the pharmacodynamic profile (PD) of LZ in patients admitted to intensive care and subjected to mechanical ventilation.
• Characterize the role of the polymorphism of the genes involved (genotypes UGT2B15 * 1/1 and UGT2B15 * 2/2) in the metabolism of LZ and correlate it with the observed PK parameters.
• Evaluate the clinical safety of PG in patients receiving intensive care and undergoing mechanical ventilation.

• Valutare la sicurezza clinica del LZ nei pazienti ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.
• Valutare la risposta clinica al LZ nei pazienti ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.
• Caratterizzare il profilo farmacodinamico (PD) del LZ nei pazienti ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.
• Caratterizzare il ruolo del polimorfismo dei geni coinvolti (genotipi UGT2B15*1/1 e UGT2B15*2/2) nel metabolismo del LZ e correlarlo con i parametri di PK osservati.
• Valutare la sicurezza clinica del PG nei pazienti ricoverati in terapia intensiva e sottoposti a ventilazione meccanica.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Written informed consent of parents or legal representatives of minors according to national law;
• Male and / or female subjects of the following ages: =1 year - <12 years;
• Critical patients subjected to mechanical ventilation and hospitalized in PICU;
• Patients naïve due to drugs for the analgosedation during ongoing hospitalization.

• Consenso informato scritto dei genitori o dei rappresentanti legali dei minori secondo la legge Nazionale;
• Soggetti di sesso maschile e/o femminile delle seguenti età: =1 anno - <12 anni;
• Pazienti critici sottoposti a ventilazione meccanica e ricoverati in PICU;
• Pazienti naïve per farmaci per l’analgosedazione durante il ricovero in corso.

E.4

Principal exclusion criteria

• Hospitalization in PICU less than 48 hours;
• Impaired renal function (estimated GFR according to Schwartz <30 mL / min / 1.73 m2 or creatininemia> 2 vn);
• Altered hepatic function (bilirubin, AST, ALT> 2 UN);
• Altered cardiac function (FE <50%);
• Need for administration of neuromuscular blocking drugs;
• Concomitant therapy with drugs in continuous infusion that contain PG (see table 2)
• Metronidazole therapy in the three months prior to entering the study.
• History of exposure to LZ in the seven days prior to enrollment in the study;
• Participation in other experimental clinical studies;
• Patient undergoing extracorporeal circulation (dialysis, ECMO)
• Known allergic reaction to LZ or its excipients;
• Weight <6 kg;
• Known immaturity of the alcohol dehydrogenase enzyme system;
• Pregnancy in progress;
• Ingestion of antifreeze;
• Treatment with silver sulfadiazine for wound care;
• Diagnosed or suspected oncological pathology.
• Valproic acid therapy

• Ricovero in PICU previsto inferiore alle 48 ore;
• Alterata funzione renale (GFR stimata secondo Schwartz < 30 mL/min/1.73 m2 o creatininemia > 2 vn);
• Alterata funzione epatica (bilirubina, AST, ALT > 2 UN);
• Alterata funzione cardiaca (FE < 50%);
• Necessità di somministrazione di farmaci bloccanti neuromuscolari;
• Terapia concomitante con farmaci in infusione continua che contengono PG (vedi tabella 2)
• Terapia con metronidazolo nei tre mesi precedenti all’ingresso nello studio.
• Storia di esposizione a LZ nei sette giorni precedenti l’arruolamento nello studio;
• Partecipazione ad altri studi clinici sperimentali;
• Paziente sottoposto a circolazione extracorporea (dialisi, ECMO)
• Reazione allergica nota al LZ o ai suoi eccipienti;
• Peso < 6 kg;
• Immaturità nota del sistema enzimatico dell’alcool deidrogenasi;
• Gravidanza in corso;
• Ingestione di antigelo;
• Trattamento con sulfadiazina d'argento per la cura delle ferite;
• Patologia oncologica diagnosticata o sospetta.
• Terapia con acido valproico

E.5 End points

E.5.1

Primary end point(s)

AUC, Cmax, Tmax, drug clearance (CL), t1 / 2, Cmin in responder patients (COMFORT-B equal to 11 - 22 and alertness score between 2 and 3) and in non-responder patients

AUC, Cmax, Tmax, clearance del farmaco (CL), t1/2, Cmin nei pazienti responder (COMFORT-B pari a 11 – 22 e score di alertness compreso tra 2 e 3) e nei pazienti non responder

E.5.1.1

Timepoint(s) of evaluation of this end point

72 hous

72 ore

E.5.2

Secondary end point(s)

Efficacy Lorazepam
• Percentage of responder patients (with COMFORT-B scale score equal to 11 - 22 and alertness score between 2 and 3), in relation to the dosage and the modalities (sequence) of administration [Time considered: From the first administration of the drug up to 72 hours].
• Median (IQR) of the COMFORT-B scale score and alertness score, in relation to the dosage and method of administration at the end of drug administration [Time considered: From the first administration of the drug up to 72 hours].
• Plasma LZ value expressed in ng / mL (Cmin, Cmax, AUC) correlated to the clinical response (COMFORT-B scale score of 11 - 22 and alertness score between 2 and 3) at the end of drug administration [ Time considered: From the first administration of the drug up to 72 hours]
Safety and tolerability Lorazepam
• Number AEs associated with interruption of the experimental drug [Time considered: From the first administration of the drug up to 72 hours];
• AEs / SAEs number at the end of the administration of the experimental drug [Time considered: From the first administration of the drug up to 72 hours] - a measure of the number and types of adverse events / adverse events encountered in relation to the dosage and modalities of administration ;
• AEs / SAEs number at the end of the follow-up [Time considered: From 72 hours from the first administration of the drug until the end of the 3rd day of follow-up] - a measure of the number and types of adverse events / adverse events encountered in relation to dosage and method of administration;
• Vital signs at the end of the administration of the experimental drug [Time considered: From the first administration of the drug up to 72 hours]. Measurements of vital signs (PA, FC, T), which assesses the clinical significance of any changes from baseline (Median (IQR)) in relation to the dosage and method of administration;
• Vital signs at the end of the follow-up [Time considered: From 72 hours from the first administration of the drug until the end of the 3rd day of follow-up]. Measurements of vital signs (PA, FC, T), which assesses the clinical significance of any changes from baseline (Median (IQR)) in relation to the dosage and method of administration;
Safety and tolerability of propylene glycol

• Plasma concentrations (AUC) of PG in serum at the end of drug administration [Time considered: From the first administration of the drug up to 72 hours];
• Osmolar GAP (detected osmolarity - calculated osmolarity) changes from baseline (Median (IQR)) in relation to dosage and method of administration [Time considered: From the first administration of the drug up to 72 hours];
• Plasma levels of early markers of renal impairment (Cystatin C) changes from baseline (Median (IQR)) in relation to dosage and modalities of administration at the end of drug administration [Time considered: From the first administration of the drug up to 72 hours].
• Urinary levels of early markers of renal impairment (NGAL) changes from baseline (Media ± SD) in relation to dosage and modalities of administration at the end of drug administration [Time considered: From the first administration of the drug up to 72 hours] .
• Indexes of renal damage (eGFR) changes from baseline (Median (IQR)) in relation to dosage and modalities of administration at the end of drug administration [Time considered: From the first administration of the drug up to 72 hours]

Efficacia Lorazepam
• Percentuale di pazienti responder (con punteggio della scala COMFORT-B pari a 11 – 22 e score di alertness compreso tra 2 e 3), in relazione al dosaggio e alle modalità (sequenza) di somministrazione [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore].
• Mediana (IQR) del punteggio della scala COMFORT-B e score di alertness, in relazione al dosaggio e alle modalità di somministrazione al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore].
• Valore plasmatico di LZ espresso in ng/mL (Cmin, Cmax, AUC) correlato alla risposta clinica (punteggio della scala COMFORT-B pari a 11 – 22 e score di alertness compreso tra 2 e 3) al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore]
Sicurezza e tollerabilità Lorazepam
• Numero AEs associati a interruzione del farmaco sperimentale [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore];
• Numero AEs / SAEs al termine della somministrazione del farmaco sperimentale [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore] - una misura del numero e dei tipi di eventi avversi / eventi avversi incontrati in relazione al dosaggio e alle modalità di somministrazione;
• Numero AEs / SAEs al termine del follow-up [Tempo considerato: Da 72 ore dalla prima somministrazione del farmaco fino alla fine del 3° giorno di follow-up] - una misura del numero e dei tipi di eventi avversi / eventi avversi incontrati in relazione al dosaggio e alle modalità di somministrazione;
• Segni vitali al termine della somministrazione del farmaco sperimentale [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore]. Misurazioni dei segni vitali (PA, FC, T), che valuta il significato clinico di eventuali cambiamenti rispetto al basale (Mediana (IQR)) in relazione al dosaggio e alle modalità di somministrazione;
• Segni vitali al termine del follow-up [Tempo considerato: Da 72 ore dalla prima somministrazione del farmaco fino alla fine del 3° giorno di follow-up]. Misurazioni dei segni vitali (PA, FC, T), che valuta il significato clinico di eventuali cambiamenti rispetto al basale (Mediana (IQR)) in relazione al dosaggio e alle modalità di somministrazione;
Sicurezza e tollerabilità del Glicole propilenico
• Concentrazioni plasmatiche (AUC) del PG in mg/L nel siero al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore];
• GAP osmolare (osmolarità rilevata – osmolarità calcolata) cambiamenti rispetto al basale (Mediana (IQR)) in relazione al dosaggio e alle modalità di somministrazione [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore];
• Livelli plasmatici dei marcatori precoci di danno renale (Cistatina C) cambiamenti rispetto al basale (Mediana (IQR)) in relazione al dosaggio e alle modalità di somministrazione al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore].
• Livelli urinari dei marcatori precoci di danno renale (NGAL) cambiamenti rispetto al basale (Media ±DS) in relazione al dosaggio e alle modalità di somministrazione al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore].
• Indici di danno renale (eGFR) cambiamenti rispetto al basale (Mediana (IQR)) in relazione al dosaggio e alle modalità di somministrazione al termine della somministrazione del farmaco [Tempo considerato: Dalla prima somministrazione del farmaco fino a 72 ore]

E.5.2.1

Timepoint(s) of evaluation of this end point

72 hours

72 ore

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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

Yes

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

minors

minori

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)

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

2020-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-27

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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