Clinical Trials Register

Summary
EudraCT Number:	2011-003730-13
Sponsor's Protocol Code Number:	OST07/11
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:	2012-07-23
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

2011-003730-13

A.3

Full title of the trial

Effects of plasma expanders administration in pregnancies complicated by intra uterine growth restriction

Effetti della somministrazione di espansori del volume plasmatico materno in gravidanze complicate da restrizione della crescita fetale

A.3.1

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

Effects of plasma expanders administration in pregnancies complicated by intra uterine growth restriction

Effetti della somministrazione di espansori del volume plasmatico materno in gravidanze complicate da restrizione della crescita fetale

A.3.2

Name or abbreviated title of the trial where available

OST07/11

A.4.1

Sponsor's protocol code number

OST07/11

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	AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
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	fondi interni assegnati all'U.O. Ostetricia budget 2012-14
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	AOU di Bologna Policlinico S.Orsola-Malpighi
B.5.2	Functional name of contact point	U.O. Ostetricia, PI Dr.Ghi
B.5.3	Address:
B.5.3.1	Street Address	Via Albertoni 15
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	051/6364411
B.5.5	Fax number	051/6364411
B.5.6	E-mail	tullio.ghi@aosp.bo.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	TETRASPAN*20SAC 500ML 60MG/ML
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.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hydroxyethyl starch (idrossietil amido)
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	60
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	Yes
D.3.11.13.1	Other medicinal product type	plasma expander

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

intra uterine growth restriction

Restrizione di crescita intrauterina

E.1.1.1

Medical condition in easily understood language

intra uterine growth restriction

Restrizione di crescita intrauterina

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10022819
E.1.2	Term	Intrauterine growth retardation
E.1.2	System Organ Class	10036585 - Pregnancy, puerperium and perinatal conditions

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10061452
E.1.2	Term	Complication of pregnancy
E.1.2	System Organ Class	10036585 - Pregnancy, puerperium and perinatal conditions

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 endpoint of this study is to evaluate, in terms of perinatal morbidity and mortality, the effects of plasma expander administration (hydroxy-methy-starch 30 ml/kg) in pregnancies complicated by intra uterine growth restriction (IUGR) (fetal weight under the tenth centile for gestational age and umbilical Doppler impairment).

Valutare l’effetto, in termini di morbilità e mortalità perinatale, della somministrazione di espansori del volume plasmatico nelle gravidanze complicate da restrizione della crescita intrauterina (peso fetale inferiore al decimo percentile per l’epoca gestazionale e alterazione del Doppler dell’arteria ombelicale)

E.2.2

Secondary objectives of the trial

Gestational age at delivery
- - Placental abruption risk
- - Time elapsed between IUGR diagnosis and delivery
- - Newborns birth weight
- - pH (from umbilical artery blood) at birth
- - Number of newborns with ultrasound detectable brain alterations.
-

Valutare,in tali gravidanze,l’effetto dell’espansione del volume plasmatico su:
- Epoca gestazionale al parto
- Rischio di distacco di placenta
- Intervallo fra la diagnosi di IUGR ed espletamento del parto
- Peso alla nascita dei neonati
- pH (da sangue arterioso cordonale) alla nascita
- Numero di neonati con alterazioni riscontrabili all’imaging ecografico cerebrale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- - Singleton pregnancies
- - Pregnancies complicated by intra uterine growth restriction (fetal weight under tenth centile for gestational age and umbilical Doppler impairment, in the form of an increased pulsatility index, absent or reversed diastolic flow)
- - IUGR diagnosed between 24th and 32nd week of gestational age
- - Age > 18 years
- - Acquisition of informed consent

Gravidanze singole
- Gravidanze complicate da restrizione della crescita intrauterina (peso fetale inferiore al decimo percentle per l’epoca gestazionale ed alterazione del doppler dell’arteria ombelicale “in the form of an increased pulsatility index, absent or reversed diastolic flow”)
- IUGR diagnosticato fra la 24ma e la 32ma settimana di epoca gestazionale
- Età > 18 anni
- Acquisizione consenso informato

E.4

Principal exclusion criteria

Maternal pathologies existing prior to pregnancy
- - Maternal complications of pregnancy (gestational hypertension, pre-eclampsia, gestational diabetes
- - Fetal morphologic abnormalities
- - Fetal chromosomal abnormalities
- - Maternal-fetal infections
- - Placentation abnormalities (placenta previa, vasa previa)
- - Metrorrhagia
- - Premature rupture of membranes
- - Drug abuse, cigarette smoking

Patologie materne pre-esistenti alla gravidanza
- Complicazioni materne della gravidanza (ipertensione gestazionale, PE, diabete gestazionale..)
- Anomalie morfologiche fetali note
- Anomalie cromosomiche fetali note
- Infezioni materno-fetali note
- Anomalie della placentazione (placenta previa, vasa previa)
- Metrorragie
- Rottura prematura delle membrane
- Assunzione di droghe o fumo di sigaretta

E.5 End points

E.5.1

Primary end point(s)

Outcome composito di mortalità e morbidità (Respiratory Distress Syndrome; RDS, Emorragia intraventricolare;IVH o sepsi) perinatale

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

16 settimane

E.5.2

Secondary end point(s)

Valutare, in tali gravidanze, l’effetto dell’espansione del volume plasmatico su:
- Epoca gestazionale al parto
- Rischio di distacco di placenta
- Intervallo fra la diagnosi di IUGR ed espletamento del parto
- Peso alla nascita dei neonati
- pH (da sangue arterioso cordonale) alla nascita
- Numero di neonati con alterazioni riscontrabili all’imaging ecografico cerebrale

E.5.2.1

Timepoint(s) of evaluation of this end point

16 weeks

16 settimane

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

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessun farmaco, semplice monitoraggio del benesser

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

F.3.3.3

Pregnant women

Yes

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.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

2012-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-17

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

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