Clinical Trials Register

Summary
EudraCT Number:	2017-000846-23
Sponsor's Protocol Code Number:	LT4032-301
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:	2021-01-21
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

2017-000846-23

A.3

Full title of the trial

Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

Valutazione dell'efficacia e della sicurezza di T4032 (bimatoprost 0,01% senza conservanti) rispetto a Lumigan® 0,01% in pazienti con ipertensione oculare o glaucoma.

A.3.1

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

Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.

Valutazione dell'efficacia e la sicurezza del nuovo collirio T4032 in confronto a Lumigan® in pazienti con ipertensione oculare o glaucoma
hypertensive or glaucomatous patients

A.3.2

Name or abbreviated title of the trial where available

In-SIGHT study

Studio In-SIGHT

A.4.1

Sponsor's protocol code number

LT4032-301

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	LABORATOIRES THEA
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	Laboratoires THEA
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	Laboratoires THEA
B.5.2	Functional name of contact point	Clinical department
B.5.3	Address:
B.5.3.1	Street Address	12, rue Louis Blériot
B.5.3.2	Town/ city	Clermont-Ferrand Cedex 2
B.5.3.3	Post code	F-63017
B.5.3.4	Country	France
B.5.4	Telephone number	0033473981436
B.5.5	Fax number	0033473981424
B.5.6	E-mail	Aude.BARDIOT@theapharma.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bimatoprost
D.3.2	Product code	[T4032]
D.3.4	Pharmaceutical form	Eye gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BIMATOPROST
D.3.9.2	Current sponsor code	T4032
D.3.9.4	EV Substance Code	SUB12470MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
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	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	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lumigan® 0.01 %
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan Pharmaceuticals Ireland
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Lumigan
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BIMATOPROST
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB12470MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
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	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	AZOPT - 10MG/ML COLLIRIO, SOSPENSIONE - USO OCULARE - FLACONE (LDPE) 5 ML - 3 FLACONI
D.2.1.1.2	Name of the Marketing Authorisation holder	ALCON LABORATORIES (UK) LTD.
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	Azopt
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Eye drops, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BRINZOLAMIDE
D.3.9.1	CAS number	138890-62-7
D.3.9.2	Current sponsor code	na
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	10
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

glaucoma, ocular hypertension

glaucoma, ipertensione oculare

E.1.1.1

Medical condition in easily understood language

over tension in the eye, glaucoma

pressione alta dell'occhio, glaucoma

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10018307
E.1.2	Term	Glaucoma and ocular hypertension
E.1.2	System Organ Class	10015919 - Eye 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 demonstrate the non-inferiority of T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy.

Dimostrare la non inferiorità a livello di efficacia delle gocce oculari senza conservante T4032 rispetto a Lumigan® 0,01%.

E.2.2

Secondary objectives of the trial

To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%.

Valutare la sicurezza e l'efficacia di T4032 rispetto a Lumigan® 0,01%.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

At Screening Visit (D-42):
-Informed consent signed and dated.
-Patient aged =18 years old.
-Both eyes with 500 µm = central corneal thickness = 600 µm.
-Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP = 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
-Both eyes with IOP = 18 mmHg.

At Randomisation Visit (D1) at 8:00:
-Both eyes with 22 mmHg = IOP < 34 mmHg and with asymmetry between eyes = 3 mmHg.

Alla visita di Screening (D-42):
1.1 Consenso informato firmato e datato.
1.2 Paziente di età =18 anni.
1.3 Entrambi gli occhi con 500 µm = spessore corneale centrale = 600 µm.
1.4 Entrambi gli occhi con diagnosi di glaucoma ad angolo aperto o ipertensione oculare, inizialmente trattati e controllati (incluso IOP = 18 mmHg) per almeno 6 mesi con qualsiasi monoterapia di prostaglandine.
1.5 Entrambi gli occhi con IOP = 18 mmHg.

Alla Visita di Randomizzazione (D1) alle 8:00:
1.6 Entrambi gli occhi con 22 mmHg = IOP <34 mm Hg e con asimmetria tra gli occhi = 3 mmHg.

E.4

Principal exclusion criteria

Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
2.1.1 Fundus examination not performed or not available within 12 months.
2.1.2 Visual field not performed or not available within 12 months.
2.1.3 Significant worsening according to the two last visual fields (at least 6 months between the two visual fields).
2.1.4 Advance stage of glaucoma, defined by at least one of the following criteria:
2.1.4.1 Absolute defect in the ten degrees central point of the visual field.
2.1.4.2 Severe visual field loss: MD < -18 dB.
2.1.4.3 Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
2.1.5 History of non-responder to bimatoprost therapy.
2.1.6 Far Best Corrected Visual Acuity = + 0.7 Log Mar (e.g., = 0.2 in decimal value or = 20/100 Snellen equivalent or = 50 ETDRS letters).
2.1.7 History of trauma, infection, clinically significant inflammation within the 3 previous months.
2.1.8 Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
2.1.9 Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment).
2.1.10 Presence of at least one severe objective sign among the following:
2.1.10.1 Conjunctival hyperaemia (Grade 5 / McMonnies scale).
2.1.10.2 Superficial punctate keratitis (Grade 4/5 / Oxford scale).
-2.1.10.3 Blepharitis (Grade 3 / 0-3 scale).
2.1.11 Severe dry eye as assessed by the investigator.
2.1.12 Corneal ulceration.
2.1.13 Any palpebral abnormality incompatible with a good
examination.
2.1.14 Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.

Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 30.

Criteri di esclusione di tipo oculare in ALMENO UN OCCHIO [2.1]:
2.1.1 Esame del fondo oculare non eseguito o non disponibile per gli ultimi 12 mesi.
2.1.2 Campo visivo non eseguito o non disponibile per gli ultimi 12 mesi.
2.1.3 Significativo peggioramento in base agli ultimi due esami del campo visivo (almeno 6 mesi di distanza tra i due esami del campo visivo).
2.1.4 Stadio avanzato del glaucoma, definito da almeno uno dei seguenti criteri:
2.1.4.1 Difetto assoluto nei dieci gradi del punto centrale del campo visivo.
2.1.4.2 Grave perdita del campo visivo: MD < -18 dB.
2.1.4.3 Rischio di peggioramento del campo visivo come conseguenza della partecipazione allo studio secondo il miglior giudizio dello sperimentatore.
2.1.5 Precedenti come non-responder alla terapia con bimatoprost.
2.1.6 Massima acuità visiva da lontano corretta = + 0,7 Log Mar (ad esempio, = 0,2 in valore decimale o = 20/100 frazione di Snellen equivalente o = 50 ETDRS).
2.1.7 Precedenti di trauma, infezione, infiammazione clinicamente significativa nei 3 mesi antecedenti.
2.1.8 Anamnesi nota o presenza di allergia oculare e/o uveite e/o infezione virale.
2.1.9 Malattia della retina clinicamente significativa o progressiva (ad es. degenerazione retinica, retinopatia diabetica, distacco di retina).
2.1.10 Presenza di almeno un segno obiettivo grave tra i seguenti:
2.1.10.1 Iperemia congiuntivale (grado 5/scala McMonnies).
2.1.10.2 Cheratite puntata superficiale (grado 4/5 / scala Oxford).
2.1.10.3 Blefarite (Grado 3 / scala 0-3).
2.1.11 Occhio secco di livello grave secondo valutazione dello sperimentatore.
2.1.12 Ulcerazione corneale.
2.1.13 Qualsiasi anomalia palpebrale che renda incompatibile una buona valutazione.
2.1.14 Qualsiasi altra anomalia che impedisca una valutazione accurata ad es. la misurazione affidabile della tonometria, l’esame del campo visivo, l’esame del fondo

Per quanto riguarda i criteri di esclusione sistemici / non relativi allo stato dell’occhio, i criteri di esclusione specifici relativi alle donne potenzialmente fertili, i criteri di esclusione relativi alle condizioni generali ed i criteri di esclusione relativi ai trattamenti precedenti e concomitanti (farmaci / terapie / procedure non medicinali) si prega di fare riferimento alla pagina 30 del protocollo di studio.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the change in the IOP in the worse eye.

L'endpoint primario di efficacia è il cambiamento della pressione intraoculare (IOP) misurata nell'occhio peggiore

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline (day 1) to Week 12 at the three time points (8:00, 10:00, 16:00).

Dal basale (Giorno 1) alla Settimana 12 nei tre intervalli temporali (8:00, 10:00, 16:00).

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints: Change in IOP in the controlateral eye.; Other efficacy endpoints will be analysed: change in IOP in the worse eye and in the controlateral eye.; Other efficacy endpoints will be analysed: efficacy assessed by the investigator.; Safety endpoint: conjunctival hyperaemia on McMonnies scale.; Safety endpoint: change in the conjunctival hyperaemia on McMonnies scale in 3 classes (improvement, no change, worsening).; Safety endpoint: score of each ocular symptom throughout the day and the sum of these scores.; Safety endpoint: acore of each ocular sympton upo instillation and the sum of these scores.; Safety endpoint: score of each ocular sign.; Safety endpoint: corneal fluorescein staining (Oxford grading scheme).; Safety endpoint: far best corrected visual acuity expressed in Log MAR.; Safety endpoint: ocular tolerance assessed by the investigator.; Safety endpoint: ocular tolerance assessed by the patient.; Safety endpoint: ocular and systemic AE by sistem organ class and preferred term.

Endpoints secondari di efficacia: modifica della IOP dell'occhio controlaterale.; Verranno analizzati altri endpoints di efficacia: modifica della IOP dell'occhio peggiore e dell'occhio controlaterale.; Verranno analizzati altri endpoint di efficacia: efficacia valutata dallo sperimentatore.; Endpoint di sicurezza: iperemia congiuntivale su scala McMonnies.; Endpoint di sicurezza: variazione dell'iperemia congiuntivale su scala McMonnies (miglioramento, nessuna variazione, peggioramento).; Endpoint di sicurezza: punteggio in ciascun sintomo oculare nell'arco della giornata e somma dei punteggi.; Endpoint di sicurezza: punteggio di ciascun sintomo oculare dopo l'installazione nell'arco della giornata e somma dei punteggi.; Endpoint di sicurezza: punteggio di ciascun segno oculare.; Endpoint di sicurezza: colorazione corneale con fluoresceina (schema di classificazione Oxford).; Endpoint di sicurezza: massima acuità visiva corretta da lontano espressa in log MAR.; Endpoint di sicurezza: tolleranza oculare valutata dallo sperimentatore.; Endpoint di sicurezza: tolleranza oculare valutata dal paziente. ; Endpoint di sicurezza: evento avverso (AE) oculare e sistemico per classe di sistema (SOC) e termine preferito (PT).

E.5.2.1

Timepoint(s) of evaluation of this end point

From Baseline to Week 12 at the three time points (8:00, 10:00, 16:00).; From baseline to week 6 at the three time points (8:00, 10:00, 16:00).; -; At week 6 and at week 12.; From baseline at week 6 and at week 12; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.; Day 1, week 6 and week 12.

Dal basale alla settimana 12 nei tre intervalli temporali (8:00, 10:00, 16:00).; Dal basale alla settimana 6 nei tre intervalli temporali (8:00, 10:00, 16:00).; -; Alla settimana 6 e alla settimana 12.; Dal basale alla settimana 6 e alla settimana 12.; Giorno 1, settimana 6 e settimana 12.; Giorno 1, settimana 6 e settimana 12.; Giorno1, settimana 6, settimana 12.; Giorno 1, settimana 6 e settimana 12.; Giorno 1, Settimana 6 e settimana 12.; Giorno 1, settimana 6 e settimana 12.; Giorno1, settimana 6 e settimana 12.; Giorno 1, settimana 6 e settimana 12.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

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

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

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Sperimentatore in cieco

Investigator-masked

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Tunisia

Ukraine

Belgium

Estonia

France

Germany

Greece

Italy

Lithuania

Poland

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

161

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

273

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

350

F.4.2.2

In the whole clinical trial

434

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, at the end of the study, patients will be treated according to standard clinical practice

Nessuno, i pazienti alla fine dello studio, saranno trattati come da pratica clinica standard

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

2018-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-30

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

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