The Use of Eculizumab in HELLP Syndrome

Completed · Phase 1

Conditions studied: HELLP Syndrome (HELLP), Third Trimester, Complement Abnormality, Morbidity;Newborn, Maternal Injury, Preeclampsia Severe

In brief

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.

Key facts

Study ID

NCT04103489

Run by

Johns Hopkins University

People needed

3

Starts

2021-02-23

Expected to finish

2023-09-04

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• The Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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