Status:
COMPLETED
The Use of Eculizumab in HELLP Syndrome
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HELLP Syndrome (HELLP), Third Trimester
Complement Abnormality
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
This research study is being performed to see if women diagnosed with early preterm Hemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome (estimated gestational ages of 23-30 weeks) benefi...
Detailed Description
Preeclampsia is a devastating multisystem disorder of pregnancy that manifests as hypertension with or without proteinuria and/or end organ damage caused by endothelial dysfunction and occurs in 3-5% ...
Eligibility Criteria
Inclusion
- Pregnant women diagnosed with HELLP syndrome less than 30 weeks gestation.
Exclusion
- Women with
- Disseminated intravascular coagulopathy
- Non-reassuring fetal status necessitating delivery
- Non-viable fetuses
- Stroke
- Fetal demise intra-utero
- Eclamptic seizure
- Known atypical hemolytic uremic syndrome
- Familial or acquired thrombocytopenia purpura
- Paroxysmal nocturnal hemoglobinuria
- Allergy to eculizumab will be excluded.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04103489
Start Date
February 23 2021
End Date
September 4 2023
Last Update
November 14 2023
Active Locations (1)
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1
The Johns Hopkins University
Baltimore, Maryland, United States, 21287