Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

Phase 2

Recruiting

• Conditions: Preeclampsia
• Interventions: Drug: Ravulizumab

• Registration Number: NCT06333652
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revulizumab Treatment	Ravulizumab	Subjects will receive an single-dose infusion of Ravulizumab.

Primary Outcome Measures

Name	Time	Method
Alternative Complement Pathway Biomarkers at time of delivery	Baseline	Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery

Secondary Outcome Measures

Name	Time	Method
Hospitalization length in the postpartum period	Approximately 3-5 days, it may vary	Length of hospital stay measured in number of days in hospital stay (peripartum period)
Meningococcal infection after use of ravulizumab	72 hours up to 3 weeks after Ravulizumab infusion	Number of participants to present a meningococcal infection after use of Ravulizumab
Clinical biomarkers of severe features of preeclampsia and HELLP syndrome	72 hours after Ravulizumab infusion	Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets
Pregnancy duration	Approximately 40 weeks	Length of pregnancy measured in number of weeks.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States