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

NCT ID: NCT05345561

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-14

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal and Neonatal Alloimmune Thrombocytopenia

Keywords

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Alloimmunization HPA-1a Fetal and Neonatal Alloimmune Thrombocytopenia Neonatal thrombocytopenia Pregnant women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Women with higher risk of FNAIT

Clinical data collection

Intervention Type OTHER

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

Interventions

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Clinical data collection

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Participants with prior history of FNAIT
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rallybio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New Horizons Clinical Trials, LLC

Chandler, Arizona, United States

Site Status

Zillan Clinical Research - Gardena

Gardena, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

St. Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Columbia University Irving Medical Center

New York, New York, United States

Site Status

New York-Presbyterian-Queens

New York, New York, United States

Site Status

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Wright State Physicians Obstetrics & Gynecology

Dayton, Ohio, United States

Site Status

Temple Perinatal Diagnosis Center

Philadelphia, Pennsylvania, United States

Site Status

Javara Inc. - Forest

Dallas, Texas, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Javara Research Inc. - Dallas - PPDS

Houston, Texas, United States

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Klinikum der Friedrich Schiller Universität Jena

Jena, Thuringia, Germany

Site Status

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status

Oslo Universitetssykehus HF, Ullevål

Oslo, Oslo County, Norway

Site Status

Universitetssykehuset Nord Norge

Tromsø, , Norway

Site Status

Barnmorskestationen Rosengård

Lund, Skåne County, Sweden

Site Status

Södersjukhuset

Stockholm, Stockholms Ian, Sweden

Site Status

Clinical Trial Consultants - Uppsala

Uppsala, Uppsala Ian, Sweden

Site Status

St. Thomas' Hospital

London, Surrey, United Kingdom

Site Status

Countries

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United States Canada Germany Netherlands Norway Sweden United Kingdom

Other Identifiers

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IPA2002

Identifier Type: -

Identifier Source: org_study_id