Complement Regulation to Undo Systemic Harm in Preeclampsia (NCT04725812) | Clinical Trial Compass
TerminatedPhase 2
Complement Regulation to Undo Systemic Harm in Preeclampsia
Stopped: PI moved institutions
United States2 participantsStarted 2021-09-13
Plain-language summary
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.
Who can participate
Age range13 Years
SexFEMALE
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Inclusion criteria
β. Provision of signed and dated informed consent form
β. Stated willingness to comply with all study procedures \& availability for study duration
β. Biologically female, aged β₯13, body weight β₯40kg
β. Diagnosed with preeclampsia between 23-29+6/7 weeks gestation, by following criteria:
β. Blood pressure β₯160 mmHg systolic or β₯110 mmHg diastolic OR
β. Blood pressure β₯140 mmHg systolic or β₯90 mmHg diastolic and at least one of the following
β. Ability to take intravenous medication and be willing to adhere to the eculizumab regimen
β. Ability to receive meningococcal vaccine and be willing to adhere to antibiotic regimen
Exclusion criteria
β. Known allergic reactions eculizumab or meningococcal vaccine
β. Febrile illness within prior 2 weeks
β. Treatment with another investigational drug within previous 6 months
β. Inpatient expectant management for preeclampsia \>72 hours prior to enrollment
β. Fetal contraindication to expectant management of pregnancy