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Recruiting NCT06333652

Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

Phase II Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ravulizumab.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

Overview

The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.

Interventions

  • Drug Ravulizumab
    Intravenous infusion 100 mg/ml

Primary outcome measures

  • Alternative Complement Pathway Biomarkers at time of delivery [Time frame: Baseline]
Secondary outcome measures (4)
  • Pregnancy duration [Time frame: Approximately 40 weeks]
  • Clinical biomarkers of severe features of preeclampsia and HELLP syndrome [Time frame: 72 hours after Ravulizumab infusion]
  • Hospitalization length in the postpartum period [Time frame: Approximately 3-5 days, it may vary]
  • Meningococcal infection after use of ravulizumab [Time frame: 72 hours up to 3 weeks after Ravulizumab infusion]

Eligibility criteria

Inclusion criteria

  • Individuals with < 34 0/7 weeks of gestation.
  • Individuals with severe preeclampsia or HELLP features.

Exclusion criteria

  • Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC).
  • Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT06333652 · 22-009239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗