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Monoclonal Antibodies

Eculizumab for HELLP Syndrome

Phase 1
Waitlist Available
Led By Arthur J Vaught
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant women diagnosed with HELLP syndrome less than 30 weeks gestation.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 72 hours
Awards & highlights

Study Summary

This trial is testing whether the drug eculizumab can help treat HELLP syndrome, a disease affecting pregnant women. The drug blocks part of the immune system. Researchers will see if the drug is effective and benefits both the mother and fetus.

Eligible Conditions
  • Maternal Injury
  • Newborn Illness
  • HELLP Syndrome
  • Complement Deficiency
  • Pre-eclampsia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in alanine aminotransferase (ALT)
Change in aspartate aminotransferase (AST) level
Body Weight Changes
Secondary outcome measures
Latency of pregnancy
Blood Transfusion
Maternal postpartum length of stay

Side effects data

From 2011 Phase 4 trial • 7 Patients • NCT00867932
71%
Headache
29%
Abdominal pain upper
29%
Cough
29%
Pyrexia
29%
Upper respiratory tract infection
25%
Menorrhagia
25%
Vaginal haemorrhage
25%
Vulvovaginal pruritus
25%
Vaginal discharge
14%
Diarrhoea
14%
Lymph node pain
14%
Fatigue
14%
Acute sinusitis
14%
Haemolysis
14%
Catheter site cellulitis
14%
Otitis media acute
14%
Nausea
14%
Nasal congestion
14%
Rhinorrhoea
14%
Acne
14%
Petechiae
14%
Rash
14%
Rash papular
14%
Contusion
14%
Blood glucose increased
14%
Decreased appetite
14%
Pain in extremity
14%
Chromaturia
14%
Skin hyperpigmentation
14%
Swelling face
14%
Hypotension
14%
Anaemia
14%
Aplastic anaemia
14%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: HELLP Syndrome at less than 30 weeks gestationExperimental Treatment1 Intervention
Women diagnosed with HELLP syndrome at 23-30 weeks gestation will receive eculizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eculizumab
FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,515 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,680,350 Total Patients Enrolled
1 Trials studying HELLP Syndrome
Arthur J VaughtPrincipal InvestigatorJohns Hopkins University
~1 spots leftby Jun 2025
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