6 completed, 5 unknown, 3 recruiting, 1 not yet recruiting. 2 Phase 3, 1 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 2 | Recruiting 2 |
| Not applicable | 1 | Completed 1 |
| Phase 2 | 1 | Terminated 1 |
Follow Thrombocytopenia, Neonatal Alloimmune: new trials by email Literature Review of Thrombocytopenia, Neonatal Alloimmune trials Research Report on Thrombocytopenia, Neonatal Alloimmune
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neonatal Thrombocytopenia in the NICU Thrombocytopenia, Neonatal Thrombocytopenia | Not yet recruiting | Assiut University | 120 | 2026-10-20 | 2026-10-20 | |
| A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone - Thrombocytopenia, Neonatal Alloimmune | Phase 3 | Recruiting | Janssen Research & Development, LLC | 50 | 2025-02-10 | 2026-09-25 |
| Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization Anti-(integrin beta-3) human monoclonal antibody - Fetal and Neonatal Alloimmune Thrombocytopenia | Phase 2 | Terminated | Rallybio | 1 | 2024-11-21 | 2026-03-06 |
| A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Nipocalimab, Placebo - Thrombocytopenia, Neonatal Alloimmune | Phase 3 | Recruiting | Janssen Research & Development, LLC | 39 | 2024-11-11 | 2026-09-25 |
| PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia Platelets - Neonatal Thrombocytopenia, Intraventricular Hemorrhage | Completed | Leiden University Medical Center | 1042 | 2022-09-26 | 2025-09-09 | |
| Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia Clinical data collection - Fetal and Neonatal Alloimmune Thrombocytopenia | Completed | Rallybio | 14390 | 2022-03-14 | 2026-03-06 | |
| The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Neonatal Thrombocytopenia, Bleeding | Recruiting | Karolinska Institutet | 250 | 2021-06-15 | 2024-10-09 | |
| Neurodevelopmental Outcome After Fetal Neonatal AlloImmune Thrombocytopenia Cognitive testing (Bayley III, WPPSI III and WISC V) - Fetal and Neonatal Alloimmune Thrombocytopenia, Long Term Adverse Effects | Unknown | Leiden University Medical Center | 78 | 2019-12-17 | 2020-08-27 | |
| Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation Neonatal Thrombocytopenia | Unknown | Boston Children's Hospital | 160 | 2019-08-19 | 2024-05-16 | |
| Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit Thrombocytopenia Neonatal | Unknown | Sylvia Elzek | 150 | 2019-03-01 | 2018-02-28 | |
| Kinetics of Blood Platelets Transfused to Healthy Subjects Platelet transfusion - Fetal and Neonatal Alloimmune Thrombocytopenia | Not applicable | Completed | Prophylix Pharma AS | 25 | 2018-04-17 | 2019-05-10 |
| Towards Routine HPA-screening In Pregnancy to Prevent FNAIT Clinical data collection. - Fetal and Neonatal Alloimmune Thrombocytopenia | Completed | Leiden University Medical Center | 3660 | 2017-03-01 | 2020-09-02 | |
| Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion - Neonatal Alloimmune Thrombocytopenia | Unknown | Xinqiao Hospital of Chongqing | 55497 | 2017-01-01 | 2016-10-17 | |
| Maternal High Blood Pressure and Newborn's Blood Profile AGA - Control group, SGA - Control group, AGA-PIH Study group - Maternal-Fetal Exchange | Completed | Romanian Society of Anesthesia and Intensive Care | 6108 | 2016-01-01 | 2017-08-29 | |
| Monitoring Outcome in Neonatal Thrombocytopenia Neonatal Thrombocytopenia, Intraventricular Hemorrhage | Completed | Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research | 700 | 2015-11-20 | 2017-08-15 | |
| Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates Neonatal Thrombocytopenia | Unknown | Boston Children's Hospital | 28 | 2013-04-01 | 2024-05-16 |
Thrombocytopenia (4) · Hemorrhage (2) · Long Term Adverse Effects (1)
Blood Platelet Disorders (16) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (16) · Cytopenia (16) · Hematologic Diseases (16) · Hemic and Lymphatic Diseases (16) · Infant, Newborn, Diseases (16) · Thrombocytopenia (12) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3)
Platelet Transfusion (2) · Immunoglobulins, Intravenous (1) · Neurologic Examination (1) · Platelet Count (1) · Prednisone (1)
Leiden University Medical Center (3) · Boston Children's Hospital (2) · Janssen Research & Development, LLC (2) · Rallybio (2) · Assiut University (1) · Karolinska Institutet (1) · Prophylix Pharma AS (1) · Romanian Society of Anesthesia and Intensive Care (1) · Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research (1) · Sylvia Elzek (1) · Xinqiao Hospital of Chongqing (1)
Netherlands (7) · Sweden (5) · United States (5) · Germany (4) · Norway (3) · Israel (2) · United Kingdom (2) · Austria (1) · Belgium (1) · Brazil (1) · Canada (1) · France (1) · Hungary (1) · Italy (1) · Poland (1)
Martha Sola-Visner, MD (2) · Alexandru Florin Rogobete, PhDs (1) · Anske van der Bom, MD PhD prof (1) · Camila Caram-Deelder, MSc/PhD (1) · Dick Oepkes, Prof MD PhD (1) · Dorel Sandesc, Prof (1) · Enrico Lopriore, MD PhD prof (1) · Enrico Lopriore, MD/PhD/Prof (1) · Enrico Lopriore, Prof. MD PhD (1) · Hilde van der Staaij, MD (1) · Ilaria Prosepe, MSc (1) · Jens Kjeldsen-Kragh, MD, PhD (1)
PMID 28859622, PMID 30819913, PMID 32690731, PMID 36933767, PMID 38407610, PMID 40720970, PMID 41290206, PMID 41461173
2023 (2), P01HL046925 (2), R01HL069990 (1)