Fetal and Neonatal Alloimmune ThrombocytopeniaNCT05345561
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
An observational study of Fetal and Neonatal Alloimmune Thrombocytopenia, run by Rallybio at 28 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal and Neonatal Alloimmune Thrombocytopenia
- What is being tested?
- Clinical data collection
- How many people
- 14,390 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 14 Mar 2022to 10 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit
Who may be able to join
- Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
Who cannot join
- Participants with prior history of FNAIT
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States19 sites
Cooper University Hospital
Camden, New Jersey, 08103
New Horizons Clinical Trials, LLC
Chandler, Arizona, 85224
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Javara Inc. - Forest
Dallas, Texas, 75230
Wright State Physicians Obstetrics & Gynecology
Dayton, Ohio, 45409
Zillan Clinical Research - Gardena
Gardena, California, 90247
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Javara Research Inc. - Dallas - PPDS
Houston, Texas, 77054
University of Miami Miller School of Medicine
Miami, Florida, 33136
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
St. Peter's University Hospital
New Brunswick, New Jersey, 08901
Yale University School of Medicine
New Haven, Connecticut, 06511
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Irving Medical Center
New York, New York, 10032
New York-Presbyterian-Queens
New York, New York, 10065
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Temple Perinatal Diagnosis Center
Philadelphia, Pennsylvania, 19140
Sweden3 sites
Barnmorskestationen Rosengård
Lund, Skåne County, 222 42
Södersjukhuset
Stockholm, Stockholms Ian, 118 83
Clinical Trial Consultants - Uppsala
Uppsala, Uppsala Ian, 752 37
Norway2 sites
Oslo Universitetssykehus HF, Ullevål
Oslo, Oslo, 0524
Universitetssykehuset Nord Norge
Tromsø, NO-9019
Germany1 site
Klinikum der Friedrich Schiller Universität Jena
Jena, Thuringia, 07747
Netherlands1 site
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
About this study
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)
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.
- Being tested
- Clinical data collection
- Keywords
- Alloimmunization, HPA-1a, Fetal and Neonatal Alloimmune Thrombocytopenia, Neonatal thrombocytopenia, Pregnant women
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women with higher risk of FNAIT Receives: Other: Clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with higher FNAIT risk characterized by race and ethnicity
Measured: At inclusion
Secondary outcomes (3)
Frequency of anti-HPA-1a maternal alloimmunization
Measured: 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
Measured: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Occurrence of neonatal thrombocytopenia
Measured: At birth or at the time of the pregnancy terminating event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start14 Mar 2022
- Primary completion31 Jan 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal and Neonatal Alloimmune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rallybio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345561
- Sponsor's protocol ID
- IPA2002
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05345561
- Acronym / sponsor ID
- IPA2002
- Keywords
- Alloimmunization, HPA-1a, Fetal and Neonatal Alloimmune Thrombocytopenia, Neonatal thrombocytopenia, Pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,390 participants (actual)
- Lead sponsor
- RallybioIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Clinical data collectionWomen with higher risk of FNAIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit
Key inclusion criteria (1 listed)
- Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
Key exclusion criteria (1 listed)
- Participants with prior history of FNAIT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical data collectionLaboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed. | Other | Pregnant women |
Primary outcome
Number of participants with higher FNAIT risk characterized by race and ethnicity
Time frame: At inclusion
3 secondary outcomes
Frequency of anti-HPA-1a maternal alloimmunization
Time frame: 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
Time frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Occurrence of neonatal thrombocytopenia
Time frame: At birth or at the time of the pregnancy terminating event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Fetal and Neonatal Alloimmune Thrombocytopenia
RecruitingPhase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
RecruitingPhase 3
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal and Neonatal Alloimmune Thrombocytopenia, run by Rallybio at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Sweden, Norway, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with higher FNAIT risk characterized by race and ethnicity (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.