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

NCT05345561 | Completed

• 1 other identifier: IPA2002
• Study Type: observational
• Target: 14,390
• Locations: 7 countries
• Sites: 28

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.

Conditions

Fetal and Neonatal Alloimmune Thrombocytopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with higher FNAIT risk characterized by race and ethnicity

  At inclusion

Secondary Outcomes (3)

• 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

Study Arms (1)

Pregnant women

Women with higher risk of FNAIT

Other: Clinical data collection

Interventions

Clinical data collection OTHER

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

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit

You may qualify if:

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

You may not qualify if:

• Participants with prior history of FNAIT

Sponsors & Collaborators

• Rallybio: lead

Study Sites (28)

New Horizons Clinical Trials, LLC

Chandler, Arizona, 85224, United States

Location

Zillan Clinical Research - Gardena

Gardena, California, 90247, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

St. Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

New York-Presbyterian-Queens

New York, New York, 10065, United States

Location

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Wright State Physicians Obstetrics & Gynecology

Dayton, Ohio, 45409, United States

Location

Temple Perinatal Diagnosis Center

Philadelphia, Pennsylvania, 19140, United States

Location

Javara Inc. - Forest

Dallas, Texas, 75230, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Javara Research Inc. - Dallas - PPDS

Houston, Texas, 77054, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Klinikum der Friedrich Schiller Universität Jena

Jena, Thuringia, 07747, Germany

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

Oslo Universitetssykehus HF, Ullevål

Oslo, Oslo County, 0524, Norway

Location

Universitetssykehuset Nord Norge

Tromsø, NO-9019, Norway

Location

Barnmorskestationen Rosengård

Lund, Skåne County, 222 42, Sweden

Location

Södersjukhuset

Stockholm, Stockholms Ian, 118 83, Sweden

Location

Clinical Trial Consultants - Uppsala

Uppsala, Uppsala Ian, 752 37, Sweden

Location

St. Thomas' Hospital

London, Surrey, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 26, 2022
• Study Start: March 14, 2022
• Primary Completion: January 31, 2025
• Study Completion: October 10, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (19); DE (1); SE (3); NL (1); NO (2); CA (1)