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NCT Number: NCT06333652

Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

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

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hemolysis Hypertension, Pregnancy-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Maria L. Gonzalez Suarez, MD,PhD

CONTACT

[email protected]

5072844083

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ravulizumab

Drug

Intravenous infusion 100 mg/ml

Other names: Ultomiris

Primary outcomes

  1. Alternative Complement Pathway Biomarkers at time of delivery

    Time frame: Baseline

    Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery

Secondary outcomes

  1. Pregnancy duration

    Time frame: Approximately 40 weeks

    Length of pregnancy measured in number of weeks.

  2. Clinical biomarkers of severe features of preeclampsia and HELLP syndrome

    Time frame: 72 hours after Ravulizumab infusion

    Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets

  3. Hospitalization length in the postpartum period

    Time frame: Approximately 3-5 days, it may vary

    Length of hospital stay measured in number of days in hospital stay (peripartum period)

  4. Meningococcal infection after use of ravulizumab

    Time frame: 72 hours up to 3 weeks after Ravulizumab infusion

    Number of participants to present a meningococcal infection after use of Ravulizumab

Study contacts

Contact information is provided by the study sponsor or research team.

Gonzalez Suarez

CONTACT

507-284-2511

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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