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NCT02899598
Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis
NA trial testing Extra blood draw samples in Neonatal Thrombocytopenia Isoimmunization Maternal-fetal. Withdrawn.
27 July 2023
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Start date | 27 July 2023 |
| Primary completion | 27 July 2023 |
| Estimated completion | 27 July 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Extra blood draw samples — full drug profile →
- extra amniotic fluid samples — full drug profile →
Conditions studied
- Neonatal Thrombocytopenia Isoimmunization Maternal-fetal — all drugs for Neonatal Thrombocytopenia Isoimmunization Maternal-fetal →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
18 and older, female only, with Neonatal Thrombocytopenia Isoimmunization Maternal-fetal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother. It is considered the equivalent of hemolytic disease of the newborn. The incidence of this disease is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic diagnosis requires the detection of anti-platelet antibodies with maternal determination of platelet phenotypes and genotypes of the two parents. The objective of this work is to develop specific molecular tools to fetal platelet genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 , HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these results with those obtained from an invasive sampling of amniotic fluid. This is a prospective study to assess the technical and diagnostic performance of a new molecular method noninvasive prenatal diagnosis of platelet genotyping.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02899598
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02899598 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 28 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02899598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing