CompletedPhase 1

The Use of Eculizumab in HELLP Syndrome

United States3 participantsStarted 2021-02-23

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in aspartate aminotransferase (AST) level

Timeframe: Baseline, 72 hours

Change in alanine aminotransferase (ALT)

Timeframe: Baseline, 72 hours

Change in lactate dehydrogenase levels (LDH)

Timeframe: Baseline, 72 hours

Trial details

NCT IDNCT04103489

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More HELLP Syndrome (HELLP), Third Trimester trials