Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
276
Countries
1
Sites
5
preeclampsia
To assess the incidence of pre-eclamspia in women who underwent a frozen embryo transfer treated with 160mg of ASA versus no treatment.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Liege
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 27 Apr 2022 → 5 Feb 2026
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516816-72-00
- EudraCT number
- 2021-000718-40
- ClinicalTrials.gov
- NCT05460416
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
To assess the incidence of pre-eclamspia in women who underwent a frozen embryo transfer treated with 160mg of ASA versus no treatment.
Conditions and MedDRA coding
preeclampsia
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment for the prevention of preeclampsia From October 2022 to October 2025
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- - Healthy women from [18 – 43] years-old, planned for a frozen embryo transfer, with natural and modified natural or HRT cycle
- - Who have given their informed consent
- - Who have a confirmed pregnancy at week 6 of amenorrhea.
Exclusion criteria 4
- - Women presenting one risk factor for preeclampsia: multiple pregnancy, history of preeclampsia, BMI > 30, lupus syndrome, preexistent proteinuria, non-treated chronic high blood pressure (>140/90), antiphospholipid antibody syndrome, diabetes (fasting blood sugar >126mg/dl)
- - Contraindication to ASA (at risk of active hemorrhage (like hemophilia, …); at risk of or who have a gastro-duodenal ulcer; at risk or how have a terminal renal or hepatic insufficiency (only if ASA is given at high dose)
- - Already treated with ASA
- - Treatment with anticoagulants or non-steroid anti-inflammatory drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean number of women suffering from preeclampsia in the treated and not treated groups.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Asaflow 80 mg, maagsapresistente tabletten
PRD9635625 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 31360 mg milligram(s)
- Max treatment duration
- 28 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- BE187512
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Liege
- Sponsor organisation
- Centre Hospitalier Universitaire De Liege
- Address
- Avenue De L'hopital 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Liege
- Contact name
- Laurie Henry
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Liege
- Contact name
- Laurie Henry
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 276 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Liege
CHU Liège, Boulevard Du Douzieme De Ligne 1, Services Delocalises, Liege
UZ Leuven
Fertility Center, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Centre de procréation médicalement assistée, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universite Libre de Bruxelles
Centre de procréation médicalement assistée, Lennikse Baan 808, 1070, Anderlecht
Chirec
Centre de procréation médicalement assistée, Boulevard Du Triomphe 201, 1160, Brussels
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-04-27 | 2022-10-25 | 2025-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-516816-72-00 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF EN 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF FR 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF NL 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Affiche EN 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Affiche FR 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Affiche NL 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Brochure EN 2024-516816-72-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Brochure FR 2024-51681672-00 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Brochure NL 2024-516816-72-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Asaflow 2024-516816-72-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-516816-72-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-20 | Belgium | Acceptable with conditions 2024-09-12
|
2024-09-12 |