Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333652
• Other study ID #: 22-009239
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Ravulizumab
Intravenous infusion 100 mg/ml

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alternative Complement Pathway Biomarkers at time of delivery	Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery	Baseline
Secondary	Pregnancy duration	Length of pregnancy measured in number of weeks.	Approximately 40 weeks
Secondary	Clinical biomarkers of severe features of preeclampsia and HELLP syndrome	Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets	72 hours after Ravulizumab infusion
Secondary	Hospitalization length in the postpartum period	Length of hospital stay measured in number of days in hospital stay (peripartum period)	Approximately 3-5 days, it may vary
Secondary	Meningococcal infection after use of ravulizumab	Number of participants to present a meningococcal infection after use of Ravulizumab	72 hours up to 3 weeks after Ravulizumab infusion