Complement Regulation to Undo Systemic Harm in Preeclampsia
(CRUSH Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRichard Burwick, MD, MPH

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Richard Burwick, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures & availability for study duration

Biologically female, aged ≥13, body weight ≥40kg

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Treatment Details

Interventions

Eculizumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: EculizumabExperimental Treatment1 Intervention

Twelve subjects in the interventional arm will receive eculizumab at an induction dose of 900mg IV weekly (q7 days) for 4 weeks followed by a dose of 1200mg IV at week 5. Thereafter, patients will receive a maintenance dose of 1200mg IV every two weeks (q14 days). The last dose of eculizumab will be given up to 48 hours post-partum, with a dose that is dependent on the dosing schedule (i.e. whether the last dose is given within the 4-week induction period or is during the maintenance phase).