Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Preeclampsia

Treatments: Drug: Ravulizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06333652

22-009239

Details and patient eligibility

About

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

Enrollment: 14 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Revulizumab Treatment

Experimental group

Description:

Subjects will receive an single-dose infusion of Ravulizumab.

Treatment:

Drug: Ravulizumab