Clinical Trials Register

Summary
EudraCT Number:	2014-001332-11
Sponsor's Protocol Code Number:	IRELANDPILOTV1
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-04-10
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

Ireland - HPRA

A.2

EudraCT number

2014-001332-11

A.3

Full title of the trial

Aspirin for Optimising Pregnancy Outcome in Pregestational Diabetes: Pilot for The IRELAND Study (Investigating the Role of Early Low-dose Aspirin iN preexisting Diabetes)

A.3.1

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

Investigating the Role of Aspirin in patients with preexisting Diabetes in order to reduce the occurance of pregnancy complications.

A.3.2

Name or abbreviated title of the trial where available

Investigating the Role of Early Low-dose Aspirin iN preexisting Diabetes - IRELAND

A.4.1

Sponsor's protocol code number

IRELANDPILOTV1

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	Royal College of Surgeons
B.1.3.4	Country	Ireland
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	Perinatal Ireland
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Perinatal Ireland
B.5.2	Functional name of contact point	LIz Tully/Fionnuala Breathnach
B.5.3	Address:
B.5.3.1	Street Address	RCSI Rotunda, Rotunda Hospital, Parnell Sq
B.5.3.2	Town/ city	Dublin 1
B.5.3.3	Post code	n/a
B.5.3.4	Country	Ireland
B.5.4	Telephone number	35314022540
B.5.5	Fax number	35314022543
B.5.6	E-mail	perinatalireland@rcsi.ie

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	Nu-Seals® 75 mg gastro-resistant coated tablets for oral ingestion that contain 75mg of the anti-platelet agent acetylsalicylic Acid as the active agent.
D.2.1.1.2	Name of the Marketing Authorisation holder	Alliance Pharmaceticals ltd.
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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	Nu-Seals® 75 mg Aspirin
D.3.4	Pharmaceutical form	Gastro-resistant tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral 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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pregestational diabetes represents a high-risk for evolution of preeclampsia (PET), with rates of PET within this group at approximately 20%. The combination of diabetes and preeclampsia places the pregnancy at heightened risk for hypoxia and stillbirth. Placental dysfunction, due to disordered early placental development, is central to the disease process.

E.1.1.1

Medical condition in easily understood language

Pre-eclampsia can lead to serious complications for mother and baby and patients with pre-exisiting diabetes are at a higher risk of developing PET. Aspirin treatment can help reduce this risk.

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 definitive IRELAND Study aims to investigate whether low-dose aspirin prescribed routinely to woman with pre-existing diabetes, initiated at 8+0 – 12 weeks’ gestation and continued until 36 weeks gestation may modify the risk of adverse perinatal outcomes related to placental dysfunction. The purpose of the pilot phase of this study is to determine rates of patient participation and compliance with aspirin therapy throughout pregnancy in this high-risk population.
Primary objectives:
1. Proportion of eligible women who agree to participate in the pilot study.
2. Compliance with the study protocol, as judged by platelet function monitoring
3. Proportion of study participants who complete the study, with complete ascertainment of laboratory markers of glycaemic control, renal function and platelet function at all scheduled timepoints

E.2.2

Secondary objectives of the trial

Examination, through dynamic platelet function assay, of antiplatelet effect among women with pregestational diabetes when compared with platelet function in diabetic women not taking antiplatelet therapy.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria
People who satisfy all of the following may be included in the study:
1. All women with type I or type II diabetes of at least 6 months duration prior to conception.
2. Ability to speak and read English
3. Singleton pregnancy at <12 weeks’ gestational age with documented fetal cardiac activity
4. Those willing to sign voluntarily a statement of informed consent to participate in the study.

E.4

Principal exclusion criteria

Exclusion criteria
The following patients will be excluded from participation in the study:
1. Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin),
2. Peptic ulcer disease
3. Known bleeding diathesis
4. Multifetal gestation
5. Severe early-onset preeclampsia in a previous pregnancy
6. Patient already on aspirin
7. Age under 18 years
8. Concurrent participation in another clinical trial

E.5 End points

E.5.1

Primary end point(s)

The pilot phase of IRELAND is expected to be underpowered to assess efficacy of aspirin on perinatal outcome. This pilot will address uptake, compliance drop-out rates and effect of low-dose aspirin on platelet function in this group.
Antiplatelet effect, compared between study (aspirin) and control (no aspirin) groups will be measured using a novel dynamic platelet assay. The biologic effect of low-dose aspirin on platelet function in this population with respect to variables that may affect bioavailability (maternal body mass index, gestational age, compliance) will also be measured.

E.5.1.1

Timepoint(s) of evaluation of this end point

4-6 months

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

No aspirin

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

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

Delivery of last patient recruited

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:

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

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

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)

Not different

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	Perinatal Ireland
G.4.3.4	Network Country	Ireland

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-06

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