Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509434-19-00

Acronym

80202135FNAIT3003

Enrollment

Registered

2024-12-10

Start date

2025-02-10

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Brief summary

Adverse outcome of death or adjudicated severe bleeding in utero, and up to the first week post birth, or platelet count at birth <30×10^9/L in a fetus/neonate

Interventions

DRUGImaavy 185 mg/mL concentrate for solution for infusion

DRUGPREDNISONE

DRUGIMMUNOGLOBULINS

DRUGNORMAL HUMAN

DRUGFOR INTRAVASCULAR ADM.

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Adverse outcome of death or adjudicated severe bleeding in utero, and up to the first week post birth, or platelet count at birth <30×10^9/L in a fetus/neonate	—

Countries

Austria, Germany, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026