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| ID | Type | Description | Link |
|---|---|---|---|
| MOM-M281-103 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women and their offspring from current pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No investigational drugs will be administered as part of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT) | GA Week 32 through GA Week 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Live Birth | Up to approximately GA Week 37 | |
| Percentage of Participants at GA Week 24 Without an IUT | Week 24 | |
| GA at First IUT |
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Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
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Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| University of Cincinnati |
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| Up to approximately GA Week 37 |
| Number of IUTs Required | Up to approximately GA Week 37 |
| Percentage of Participants With Fetal Hydrops | Post-Birth through Age 3 Months |
| Percentage of Neonates Requiring Phototherapy | Post-Birth through Age 3 Months |
| Percentage of Neonates Requiring Exchange Transfusions | Post-Birth through Age 3 Months |
| Number of days of phototherapy required by neonate | Post-Birth through Age 3 Months |
| Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life | Post-Birth through Age 3 Months |
| Number of Simple Transfusions Required by Neonate in the First 3 Months of Life | Post-Birth through Age 3 Months |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Liverpool Hospital | Liverpool | 2170 | Australia |
| The Royal Women's Hospital | Parkville | 3052 | Australia |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| The University of British Columbia | Vancouver | British Columbia | V6H 3N1 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G1X5 | Canada |
| Centre Hospitalier Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Justus-Liebig-Universität Gießen, Kinderherzzentrum | Giessen | 35392 | Germany |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Hosp Clinic de Barcelona | Barcelona | 08028 | Spain |
| Hosp. Univ. San Cecilio | Granada | 18016 | Spain |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | SE-141 86 | Sweden |
| Queen Elizabeth Hospital | Edgbaston | B15 2TG | United Kingdom |
| University College London Hospitals NHSFT | London | WC1E 6DB | United Kingdom |
| ID | Term |
|---|---|
| D004899 | Erythroblastosis, Fetal |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D007154 | Immune System Diseases |
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