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

Active, not recruiting

• Conditions: Fetal and Neonatal Alloimmune Thrombocytopenia
• Interventions: Other: Clinical data collection

• Registration Number: NCT05345561
• Lead Sponsor: Rallybio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30000

Inclusion Criteria

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

Exclusion Criteria

• Participants with prior history of FNAIT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Clinical data collection	Women with higher risk of FNAIT

Primary Outcome Measures

Name	Time	Method
Number of participants with higher FNAIT risk characterized by race and ethnicity	At inclusion

Secondary Outcome Measures

Name	Time	Method
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
Frequency of anti-HPA-1a maternal alloimmunization	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

Trial Locations

Locations (28)

Javara Research Inc. - Dallas - PPDS; 🇺🇸 Houston, Texas, United States

Universitetssykehuset Nord Norge; 🇳🇴 Tromsø, Norway

Barnmorskestationen Rosengård; 🇸🇪 Lund, Skane, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Stockholms Ian, Sweden

Clinical Trial Consultants - Uppsala; 🇸🇪 Uppsala, Uppsala Ian, Sweden

St. Thomas' Hospital; 🇬🇧 London, Surrey, United Kingdom

New Horizons Clinical Trials, LLC; 🇺🇸 Chandler, Arizona, United States

Zillan Clinical Research - Gardena; 🇺🇸 Gardena, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

St. Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Rutgers New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

New York-Presbyterian-Queens; 🇺🇸 New York, New York, United States

Weill Cornell Medicine-New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Wright State Physicians Obstetrics & Gynecology; 🇺🇸 Dayton, Ohio, United States

Temple Perinatal Diagnosis Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Javara Inc. - Forest; 🇺🇸 Dallas, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Klinikum der Friedrich Schiller Universität Jena; 🇩🇪 Jena, Thüringen, Germany

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Oslo Universitetssykehus HF, Ullevål; 🇳🇴 Oslo, Norway