Clinical Trials Register

Summary
EudraCT Number:	2016-003361-25
Sponsor's Protocol Code Number:	SHP640-303
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:	2020-12-09
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

2016-003361-25

A.3

Full title of the trial

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

Studio in doppio cieco di fase 3, multicentrico, randomizzato volto a valutare l¿efficacia clinica e la sicurezza della sospensione oftalmica SHP640 (PVP-iodio 0,6% e desametasone 0,1%) rispetto al placebo nel trattamento della congiuntivite batterica

A.3.1

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

SHP640 in the Treatment of Bacterial Conjunctivitis

SHP640 nel trattamento della congiuntivite batterica

A.3.2

Name or abbreviated title of the trial where available

SHP640 in the Treatment of Bacterial Conjunctivitis

SHP640 nel trattamento della congiuntivite batterica

A.4.1

Sponsor's protocol code number

SHP640-303

A.5.4

Other Identifiers

Name:

IND number

Number:

75,723

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/313/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SHIRE HUMAN GENETIC THERAPIES, INC
B.1.3.4	Country	United States
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	Shire Human Genetic Therapies, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire Human Genetic Therapies, Inc.
B.5.2	Functional name of contact point	Study Manager
B.5.3	Address:
B.5.3.1	Street Address	300 Shire Way
B.5.3.2	Town/ city	Lexington
B.5.3.3	Post code	02421
B.5.3.4	Country	United States
B.5.4	Telephone number	0017812663941
B.5.5	Fax number	0
B.5.6	E-mail	sgust-c@shire.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	SHP640
D.3.2	Product code	SHP640
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	PVP-I
D.3.2	Product code	PVP-I
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Eye drops, solution
D.8.4	Route of administration of the placebo	Ocular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bacterial Conjunctivitis

Congiuntivite batterica

E.1.1.1

Medical condition in easily understood language

pink eye

Occhi rosa

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	PT
E.1.2	Classification code	10061784
E.1.2	Term	Conjunctivitis bacterial
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).

L¿obiettivo primario di questo studio ¿ valutare l¿efficacia di SHP640 in base alla risoluzione clinica (definita come assenza di iniezione congiuntivale bulbare e secrezione congiuntivale oculare) rispetto al placebo nel trattamento di soggetti affetti da congiuntivite batterica a carico dell¿occhio oggetto di studio alla Visita 3 (Giorno 5).

E.2.2

Secondary objectives of the trial

The key secondary objective of this study is to evaluate the efficacy of SHP640 based on bacterial eradication (defined as absence of all bacterial species present at or above pathological threshold at baseline) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).

L¿obiettivo secondario principale di questo studio ¿ valutare l¿efficacia di SHP640 in base all¿eradicazione batterica (definita come assenza di tutte le specie batteriche presenti alla o al di sopra della soglia patologica al basale) rispetto al placebo nel trattamento di soggetti affetti da congiuntivite batterica a carico dell¿occhio oggetto di studio alla Visita 3 (Giorno 5).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Main Inclusion Criteria:
-Subjects of any age at Visit 1 (Note: subjects <3 months of age at Visit 1 must have been full-term, ie =37 weeks gestational age at birth).
-Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
-Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
-Report presence of signs and/or symptoms of bacterial conjunctivitis for =< 4 days prior to Visit 1
-Bulbar conjunctival injection: a grade of =1 on 0-<
4 scale of Bulbar Conjunctival Injection Scale
-Ocular conjunctival discharge: a grade of =1
(mild) on a 0-3 scale of Ocular Conjunctival
Discharge Scale
-Be willing to discontinue contact lens wear for the duration of the study.

Full list of Inclusion criteria can be found in the protocol.

Criteri inclusione principali:
-Soggetti di qualsiasi età alla Visita 1 (Nota: i soggetti di età <3 mesi alla Visita 1 devono essere nati a termine, ovvero =37 settimane di età gestazionale alla nascita).
-Negatività al test AdenoPlus® per entrambi gli occhi entro 24 ore dalla Visita 1 o alla Visita 1.
-Diagnosi clinica di congiuntivite batterica sospetta in almeno 1 occhio confermata dalla presenza dei seguenti segni clinici e sintomi minimali nello stesso occhio:
-presenza riferita di segni e/o sintomi di
congiuntivite batterica per =< 4 giorni prima della
Visita 1;
-iniezione congiuntivale bulbare: un grado =1 su
una scala da 0 a 4 della Scala dell’iniezione
congiuntivale bulbare;
-secrezione congiuntivale oculare: un grado =1
(lieve) su una scala da 0 a 3 della Scala della
secrezione congiuntivale oculare.
-Disponibilità a interrompere l’uso di lenti a contatto per la durata dello studio.

Per la lista completa dei criteri di inclusione si faccia riferimento al Protocollo

E.4

Principal exclusion criteria

Main Exclusion Criteria:
-Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator’s discretion.
-Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
-Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
-Have a history of ocular surgical intervention within =6 months prior to Visit 1 or planned for the period of the study.
-Have a preplanned overnight hospitalization during the period of the study.
-Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
-Have active or a history of ocular herpes.
-Have at enrollment or within =< 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of of non-infectious
conjunctivitis (except presumed seasonal/perennial allergic
conjunctivitis), or non-bacterial ocular infection (eg, viral, fungal,
acanthamoebal, or other parasitic). Note: history or concomitant
presence of presumed seasonal or perennial allergic conjunctivitis
signs/symptoms is not exclusionary.
-Neonates or infants (ie. subjects less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
-Neonates or infants (ie. subjects less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
-Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
-Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
-Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma, be a glaucoma suspect.
-Have any known clinically significant optic nerve defects.
-Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
-Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.

Full list of Exclusion criteria can be found in the protocol.

Criteri esclusione principali:
-Malattia in corso o ricorrente che potrebbe influire sull’azione, l’assorbimento o la distribuzione del prodotto sperimentale oppure sulle valutazioni cliniche o di laboratorio, a discrezione dello sperimentatore.
-Anamnesi attuale o rilevante di malattia psichica o psichiatrica, qualsiasi disturbo medico che potrebbe far sì che il soggetto probabilmente non completi l’intero studio o qualsiasi condizione che comporti un rischio ingiustificato derivante dal prodotto sperimentale o dalle procedure.
-Intolleranza o ipersensibilità nota o sospetta al prodotto sperimentale, a composti strettamente correlati o a qualsiasi ingrediente specificato
-Anamnesi di intervento chirurgico agli occhi entro =6 mesi prima della Visita 1 o programmato durante il periodo dello studio.
-Ricovero notturno già programmato durante il periodo dello studio.
-Presenza di qualsiasi infiammazione oculare intraoculare, corneale o congiuntivale (es. uveite, irite, cheratite ulcerosa, blefarocongiuntivite cronica) diversa dalla congiuntivite batterica.
-Herpes oculare in fase attiva o riportata nell’anamnesi.
-Presentazione clinica all’arruolamento o entro =< 30 giorni dalla Visita 1 più coerente con la diagnosi di congiuntivite non infettiva (eccetto congiuntiviti allergiche stagionali/perenni) o infezione oculare non batterica (es. virale, fungina, da Acanthamoeba o da altro parassita). nota: storia o presenza concomitante di segni/sintomi di congiuntivite allergica presunta stagionale o perenne non è un'esclusione.
-Neonati o bambini piccoli (ovvero, soggetti di età <12 mesi) che presentano una congiuntivite sospetta o confermata (in base ai risultati di eventuali test eseguiti prima dello screening) di origine gonococcica, clamidiale, erpetica o chimica.
-Neonati o bambini piccoli (ovvero, soggetti di età <12 mesi) la cui madri biologiche abbiano avuto una qualsiasi malattia a trasmissione sessuale entro 1 mese dal parto o una qualsiasi anamnesi di herpes genitale.
-Presenza di ostruzione dei dotti lacrimali alla Visita 1 (Giorno 1).
-Presenza di qualsiasi condizione oftalmica significativa (es. retinopatia della prematurità, cataratta congenita, glaucoma congenito) o altro disturbo congenito con coinvolgimento oftalmico che potrebbe influire sulle variabili dello studio.
-Soggetti con responsività nota agli steroidi per la pressione intraoculare (IOP), anamnesi nota di glaucoma, glaucoma sospetto
-Presenza di qualsiasi difetto noto del nervo ottico clinicamente significativo.
-Anamnesi di sindrome dell’erosione corneale ricorrente, di origine idiopatica o secondaria a precedenti traumi corneali o sindrome dell’occhio secco; presenza di difetto dell’epitelio corneale o qualsiasi opacità corneale significativa alla Visita 1.
-Presenza di condizione attiva significativa nel segmento posteriore che richieda un trattamento invasivo (es. trattamento intravitreale con inibitori del fattore di crescita vascolare endoteliale o corticosteroidi) e che potrebbe progredire durante il periodo di partecipazione allo studio.

Per la lista completa dei criteri di esclusione si faccia riferimento al Protocollo

E.5 End points

E.5.1

Primary end point(s)

Clinical resolution status (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) in the study eye at Visit 3 (Day 5) between SHP640 and placebo.

Stato della risoluzione clinica (definita come l’assenza di iniezione congiuntivale bulbare e secrezione congiuntivale oculare) nell’occhio oggetto di studio alla Visita 3 (Giorno 5) tra SHP640 e placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3 (Day 5)

Visita 3 (giorno 5)

E.5.2

Secondary end point(s)

Key Secondary Efficacy Endpoints:
1.Bacterial eradication status (defined as absence of all bacterial species
present at or above pathological threshold at baseline) in the study eye
at Visit 3 (Day 5) between SHP640 and placebo.
Secondary Efficacy Endpoints:
2. Clinical resolution status of bacterial conjunctivitis at Visits 2 (Day 3),
4 (Day 8), and 5 (Day 12) in the study eye
3. Bacterial eradication status (defined as absence of all bacterial
species present at or above pathological threshold at baseline) as
assessed by bacterial culture at Visits 2 (Day 3), 4 (Day 8), and 5 (Day
12) in the study eye
4. Absolute and change from baseline of the individual clinical signs
(bulbar conjunctival injection and ocular conjunctival discharge) at Visits
2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
5.The global clinical score (defined as the sum of bulbar conjunctival
injection and ocular conjunctival discharge) and change from baseline in
the global clinical score at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5
(Day 12) in the study eye
6. Modified clinical resolution status, defined as a global clinical score of
0 or 1, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the
study eye
7. Expanded clinical resolution status, defined as a global clinical score
of 0, 1, or 2 with neither injection nor discharge having a score of 2, at
Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
8. Time to clinical resolution based upon assessments at Visits 2 (Day 3),
3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
9. Use of rescue medication
Safety Endpoints:
- BCVA
- Slit lamp biomicroscopy
- Non-dilated/dilated fundus examination
- Urine pregnancy testing
- Adverse events

Endpoint di efficacia secondari:
¿ Stato della risoluzione clinica della congiuntivite batterica alle Visite 2 (Giorno 3), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Stato dell¿eradicazione batterica (definita come l¿assenza di tutte le specie batteriche presenti alla o al di sopra della soglia patologica al basale) valutata mediante coltura batterica alle Visite 2 (Giorno 3), 4 (Giorno 8) e 5 (giorno 12) nell¿occhio oggetto di studio.
¿ Valore assoluto e variazione rispetto al basale nei segni clinici individuali (iniezione congiuntivale bulbare e secrezione congiuntivale oculare) alle Visite 2 (Giorno 3), 3 (Giorno 5), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Punteggio clinico globale (definito come la somma di iniezione congiuntivale bulbare e secrezione congiuntivale oculare) e variazione rispetto al basale nel punteggio clinico globale alle Visite 2 (Giorno 3), 3 (Giorno 5), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Stato della risoluzione clinica modificata, definita come un punteggio clinico globale di 0 o 1, alle Visite 2 (Giorno 3), 3 (Giorno 5), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Stato della risoluzione clinica espansa, definita come un punteggio clinico globale di 0, 1 o 2 senza iniezione n¿ secrezione con un punteggio di 2 alle Visite 2 (Giorno 3), 3 (Giorno 5), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Tempo alla risoluzione clinica basata sulle valutazioni alle Visite 2 (Giorno 3), 3 (Giorno 5), 4 (Giorno 8) e 5 (Giorno 12) nell¿occhio oggetto di studio.
¿ Uso di farmaci di soccorso
Endpoint di sicurezza:
¿ BCVA
¿ Biomicroscopia con lampada a fessura
¿ Esame del fondo oculare con pupilla non dilatata/dilatata
¿ Test di gravidanza sulle urine (per le donne in et¿ fertile)
¿ Eventi avversi (EA)

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Visit 3 (Day 5)
2. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
3. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
4. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
5. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
6. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
7. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
8. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
9. throughout the study duration
Safety Endpoints: throughout the study duration

1.Visita 3 (giorno 5)
2. Visite 2 (giorno 3), 4 (giorno 8), e 5 (giorno 12)
3. Visite 2 (giorno 3), 4 (giorno8), and 5 (giorno 12)
4. Visite 2 (giorno 3), 3 (giorno 5), 4 (giorno 8), e 5 (giorno 12)
5. Visite 2 (giorno 3), 3 (giorno 5), 4 (giorno 8), e 5 (giorno 12)
6. Visite 2 (giorno 3), 3 (giorno 5), 4 (giorno 8), e 5 (giorno 12)
7. Visite 2 (giorno 3), 3 (giorno 5), 4 (giorno 8), e 5 (giorno 12)
8. Visite 2 (giorno 3), 3 (giorno 5), 4 (giorno 8), e 5 (giorno 12)
9. per tutta la durata di studio
Safety Endpoints: per tutta la durata di studio

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

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Austria

Canada

Colombia

France

Germany

Hungary

India

Israel

Italy

Peru

Philippines

Poland

South Africa

Spain

United Kingdom

United States

Estonia

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

Ultima visita dell'ultimo paziente

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)

Yes

F.1.1.3.1