The Use of Eculizumab in HELLP Syndrome

• Status: Recruiting
• Trial end date: 2023-01-04
• Target enrollment: 0
• Participant gender: Female

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) benefit from a medication called eculizumab (ECU). This drug blocks a part of the immune system called complement. By blocking this part of the immune system, eculizumab may stop or reverse the progression of the HELLP syndrome disease. The investigators will also look to see if this drug is effective and benefits both the mother and fetus.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

• Pregnant women diagnosed with HELLP syndrome less than 30 weeks gestation.

Exclusion Criteria:

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.