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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%
Haemolysis
14%
Lymph node pain
14%
Fatigue
14%
Acute sinusitis
14%
Catheter site cellulitis
14%
Otitis media acute
14%
Diarrhoea
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
2,256 Previous Clinical Trials
14,820,068 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,738 Total Patients Enrolled
1 Trials studying HELLP Syndrome
Arthur J VaughtPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is able to partake in this clinical experiment?

"To be eligible for the trial, patients must possess a complement abnormality and lie between 18-50 years of age. Currently, 15 individuals are taking part in this experiment."

Answered by AI

Is this program pioneering a new approach to treatment?

"Investigated since 2016, Eculizumab was initially trialled by Alexion Pharmaceuticals with a sample size of 270. Subsequent Phase 3 trials led to its drug approval in the same year and today there are 13 active research projects spanning 42 countries accross 121 cities."

Answered by AI

Does this experiment stipulate an age limit, and if so, what is it?

"Patients who are between 18 and 50 years of age have the opportunity to participate in this medical study."

Answered by AI

What potential risks are associated with taking Eculizumab?

"As it is a Phase 1 trial, the data available regarding Eculizumab's safety and efficacy are still scant. Consequently, our team at Power assigned it a rating of 1 on their scale."

Answered by AI

In what medical scenarios is Eculizumab frequently prescribed?

"Eculizumab is a useful therapy for treating three distinct illnesses: myasthenia gravis, generalized; neuromyelitis optica; paroxysmal nocturnal haemoglobinuria (PNH)."

Answered by AI

Can you provide a rundown of previous trials conducted involving Eculizumab?

"Presently, 13 distinct clinical trials are examining the efficacy of Eculizumab. Among them, 8 studies have progressed into Phase 3. These research efforts mainly occur in Whittier, California; however, there is a total 594 locations hosting such experiments worldwide."

Answered by AI

What is the applicant quota for this research project?

"Correct. Data hosted on clinicaltrials.gov affirms that this medical investigation, which was initially publicized on February 23rd 2021, is actively recruiting participants. A total of 15 individuals are needed for the trial at a single site."

Answered by AI

Are there still openings for enrollment in this clinical experiment?

"According to the records published on clinicaltrials.gov, this experimental trial is actively seeking participants since its first posting in February 2021 and most recent update in June of the same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Use of Eculizumab in HELLP Syndrome
2021. "The Use of Eculizumab in HELLP Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04103489.
~1 spots leftby Apr 2025
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