Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06333652

Enrollment

Registered

2024-03-27

Start date

2026-09-01

Completion date

2028-12-31

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Hemolysis, Elevated Liver enzymes, Low Platelets

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.

Interventions

DRUGRavulizumab

Intravenous infusion 100 mg/ml

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pregnancy duration	Approximately 40 weeks	Length of pregnancy measured in number of weeks.
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
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

Countries

United States

Contacts

CONTACTGonzalez Suarez

507-284-2511

PRINCIPAL_INVESTIGATORMaria Lourdes Gonzalez Suarez, MD, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026