Health TrialsbyHealthPanel

Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

ConditionPreeclampsia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with < 34 0/7 weeks of gestation.

Individuals with severe preeclampsia or HELLP features.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Ravulizumab

    Drug

    Intravenous infusion 100 mg/ml

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: Revulizumab TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Alternative Complement Pathway Biomarkers at time of delivery

Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery

Time frame
Baseline

Secondary outcomes

1

Pregnancy duration

Length of pregnancy measured in number of weeks.

Time frame
Approximately 40 weeks
2

Clinical biomarkers of severe features of preeclampsia and HELLP syndrome

Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets

Time frame
72 hours after Ravulizumab infusion
3

Hospitalization length in the postpartum period

Length of hospital stay measured in number of days in hospital stay (peripartum period)

Time frame
Approximately 3-5 days, it may vary
4

Meningococcal infection after use of ravulizumab

Number of participants to present a meningococcal infection after use of Ravulizumab

Time frame
72 hours up to 3 weeks after Ravulizumab infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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