Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

Sponsor

Rallybio IPA, LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05345561

Collaborator

(none)

30,000

Enrollment

Locations

24.6

Anticipated Duration (Months)

2500

Patients Per Site

101.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.

Condition or Disease	Intervention/Treatment	Phase
Fetal and Neonatal Alloimmune Thrombocytopenia	Other: Clinical data collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women Women with higher risk of FNAIT	Other: Clinical data collection Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.

Arm

Intervention/Treatment

Pregnant women

Women with higher risk of FNAIT

Other: Clinical data collection

Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.

Outcome Measures

Primary Outcome Measures

Number of participants with higher FNAIT risk characterized by race and ethnicity [At inclusion]

Secondary Outcome Measures

Frequency of anti-HPA-1a maternal alloimmunization [At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event]
Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth [At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event]
Occurrence of neonatal thrombocytopenia [At birth or at the time of the pregnancy terminating event]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnant women (≥ 18 years of age) who have provided informed consent for the study.

Exclusion Criteria:

Participants with prior history of FNAIT

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Horizons Clinical Trials, LLC	Chandler	Arizona	United States	85224
2	Columbia University Irving Medical Center	New York	New York	United States	10032
3	New York-Presbyterian-Queens	New York	New York	United States	10065
4	Weill Cornell Medicine-New York Presbyterian Hospital	New York	New York	United States	10065
5	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
6	Wright State Physicians Obstetrics & Gynecology	Dayton	Ohio	United States	45409
7	Javara Inc. Texas Health Care, PLLC	Dallas	Texas	United States	75230
8	Javara Research Inc. - Dallas	Houston	Texas	United States	77054
9	Klinikum der Friedrich Schiller Universität Jena	Jena		Germany
10	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland	Netherlands	2333 ZA
11	Oslo Universitetssykehus HF, Ullevål	Oslo		Norway	0450
12	Universitetssykehuset Nord Norge	Tromsø		Norway	NO-9019