Trials / Completed
CompletedNCT03755128
A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No investigational drugs will be administered as part of the study |
Timeline
- Start date
- 2019-01-16
- Primary completion
- 2023-09-22
- Completion
- 2023-09-22
- First posted
- 2018-11-27
- Last updated
- 2025-09-12
Locations
18 sites across 9 countries: United States, Australia, Belgium, Canada, Germany, Netherlands, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT03755128. Inclusion in this directory is not an endorsement.