Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

NCT ID: NCT06333652

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Preeclampsia

Keywords

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Hemolysis Elevated Liver enzymes Low Platelets

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revulizumab Treatment

Subjects will receive an single-dose infusion of Ravulizumab.

Group Type EXPERIMENTAL

Ravulizumab

Intervention Type DRUG

Intravenous infusion 100 mg/ml

Interventions

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Ravulizumab

Intravenous infusion 100 mg/ml

Intervention Type DRUG

Other Intervention Names

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Ultomiris

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Maria Lourdes Gonzalez Suarez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Lourdes Gonzalez Suarez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gonzalez Suarez

Role: CONTACT

Phone: 507-284-2511

Facility Contacts

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Maria L. Gonzalez Suarez, MD,PhD

Role: primary

Related Links

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Other Identifiers

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22-009239

Identifier Type: -

Identifier Source: org_study_id