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

Fetal and Neonatal Alloimmune Thrombocytopenia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345561
• Other study ID #: IPA2002
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Rallybio IPA, LLC
• Contact: Chief Medical Officer
• Phone: (203) 859-3820
• Email: clinicaltrials[@]rallybio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: June 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Participants with prior history of FNAIT

Related Conditions & MeSH terms

• Fetal and Neonatal Alloimmune Thrombocytopenia
• Thrombocytopenia

Intervention

Other:
• Clinical data collection
Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Germany	Klinikum der Friedrich Schiller Universität Jena	Jena	Thüringen
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Norway	Oslo Universitetssykehus HF, Ullevål	Oslo
Norway	Universitetssykehuset Nord Norge	Tromsø
Sweden	Barnmorskestationen Rosengård	Lund	Skane
Sweden	Södersjukhuset	Stockholm	Stockholms Ian
Sweden	Clinical Trial Consultants - Uppsala	Uppsala	Uppsala Ian
United Kingdom	St. Thomas' Hospital	London	Surrey
United States	Cooper University Hospital	Camden	New Jersey
United States	New Horizons Clinical Trials, LLC	Chandler	Arizona
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	Javara Inc. - Forest	Dallas	Texas
United States	Wright State Physicians Obstetrics & Gynecology	Dayton	Ohio
United States	Zillan Clinical Research - Gardena	Gardena	California
United States	Javara Research Inc. - Dallas - PPDS	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	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	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Temple Perinatal Diagnosis Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rallybio IPA, LLC

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with higher FNAIT risk characterized by race and ethnicity		At inclusion
Secondary	Frequency of anti-HPA-1a maternal alloimmunization		At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Secondary	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
Secondary	Occurrence of neonatal thrombocytopenia		At birth or at the time of the pregnancy terminating event