Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-02-07 @ 12:31 PM
Study NCT ID:
NCT05345561
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054098', 'term': 'Thrombocytopenia, Neonatal Alloimmune'}], 'ancestors': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14390}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with higher FNAIT risk characterized by race and ethnicity', 'timeFrame': 'At inclusion'}], 'secondaryOutcomes': [{'measure': 'Frequency of anti-HPA-1a maternal alloimmunization', 'timeFrame': 'At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event'}, {'measure': 'Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth', 'timeFrame': 'At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event'}, {'measure': 'Occurrence of neonatal thrombocytopenia', 'timeFrame': 'At birth or at the time of the pregnancy terminating event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alloimmunization', 'HPA-1a', 'Fetal and Neonatal Alloimmune Thrombocytopenia', 'Neonatal thrombocytopenia', 'Pregnant women'], 'conditions': ['Fetal and Neonatal Alloimmune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women (≥ 18 years of age) who have provided informed consent for the study.\n\nExclusion Criteria:\n\n* Participants with prior history of FNAIT'}, 'identificationModule': {'nctId': 'NCT05345561', 'briefTitle': 'Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rallybio'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'IPA2002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Women with higher risk of FNAIT', 'interventionNames': ['Other: Clinical data collection']}], 'interventions': [{'name': 'Clinical data collection', 'type': 'OTHER', 'description': 'Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'New Horizons Clinical Trials, LLC', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '90247', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Zillan Clinical Research - Gardena', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian-Queens', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians Obstetrics & Gynecology', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple Perinatal Diagnosis Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Javara Inc. - Forest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Javara Research Inc. - Dallas - PPDS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Klinikum der Friedrich Schiller Universität Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '0524', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus HF, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': 'NO-9019', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Universitetssykehuset Nord Norge', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '222 42', 'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Barnmorskestationen Rosengård', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '118 83', 'city': 'Stockholm', 'state': 'Stockholms Ian', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '752 37', 'city': 'Uppsala', 'state': 'Uppsala Ian', 'country': 'Sweden', 'facility': 'Clinical Trial Consultants - Uppsala', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'SE1 7EH', 'city': 'London', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': "St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rallybio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}