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The Use of Eculizumab in HELLP Syndrome

NCT04103489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Eculizumab

Participants will receive eculizumab at diagnosis of HELLP syndrome. Participants will receive a maximum of 4 doses.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Arthur J Vaught · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2023-08-31
Completion
2023-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103489 on ClinicalTrials.gov