Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

NCT06333652 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-009239
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Hemolysis; Elevated Liver enzymes; Low Platelets

Outcome Measures

Primary Outcomes (1)

• Alternative Complement Pathway Biomarkers at time of delivery

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

  Baseline

Secondary Outcomes (4)

• Pregnancy duration

  Approximately 40 weeks

• Clinical biomarkers of severe features of preeclampsia and HELLP syndrome

  72 hours after Ravulizumab infusion

• Hospitalization length in the postpartum period

  Approximately 3-5 days, it may vary

• Meningococcal infection after use of ravulizumab

  72 hours up to 3 weeks after Ravulizumab infusion

Study Arms (1)

Revulizumab Treatment

EXPERIMENTAL

Subjects will receive an single-dose infusion of Ravulizumab.

Drug: Ravulizumab

Interventions

Ravulizumab DRUG

Intravenous infusion 100 mg/ml

Also known as: Ultomiris

Revulizumab Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pre-Eclampsia; Hemolysis

Interventions

ravulizumab

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Lourdes Gonzalez Suarez, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalez Suarez

CONTACT

507-284-2511

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)