Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

April 19, 2024 updated by: Maria Lourdes Gonzalez Suarez, Mayo Clinic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revulizumab Treatment
Subjects will receive an single-dose infusion of Ravulizumab.
Drug: Ravulizumab
Intravenous infusion 100 mg/ml
Other Names:
  • Ultomiris

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy duration
Time Frame: Approximately 40 weeks
Length of pregnancy measured in number of weeks.
Approximately 40 weeks
Clinical biomarkers of severe features of preeclampsia and HELLP syndrome
Time Frame: 72 hours after Ravulizumab infusion
Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets
72 hours after Ravulizumab infusion
Hospitalization length in the postpartum period
Time Frame: Approximately 3-5 days, it may vary
Length of hospital stay measured in number of days in hospital stay (peripartum period)
Approximately 3-5 days, it may vary
Meningococcal infection after use of ravulizumab
Time Frame: 72 hours up to 3 weeks after Ravulizumab infusion
Number of participants to present a meningococcal infection after use of Ravulizumab
72 hours up to 3 weeks after Ravulizumab infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Maria Lourdes Gonzalez Suarez, MD, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-009239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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