NCT04725812

Complement Regulation to Undo Systemic Harm in Preeclampsia

Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to determine if eculizumab is an effective treatment to prolong pregnancy in women with preeclampsia, compared to a historical control group of women that received standard of care alone. Eligible subjects will be women with preeclampsia before 30 weeks gestation, who have been deemed suitable for prolongation of pregnancy. The primary research procedure is administration of the study drug, eculizumab, by intravenous infusions weekly for four weeks, then every other week. Eculizumab is approved by the FDA for the treatment of women with atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria and is frequently used in pregnant women with these disorders. However, eculizumab is considered investigational in this study because it has not been approved by the FDA for use in patients with preeclampsia. Subject participation will last approximately 8-12 weeks on average, and the study drug will be continued until 48 hours after delivery in the treatment arm. All subjects will be followed at 2 weeks and 6 weeks after delivery to assess maternal and neonatal outcomes. A later visit may be required to complete the meningococcal vaccine schedule. The investigators believe that eculizumab will prolong pregnancy in women with preeclampsia diagnosed before 30 weeks gestation with overactive complement. As there is no effective treatment for preeclampsia other than delivery currently, women with preeclampsia before 30 weeks gestation are managed using a "watch and wait" approach (i.e., expectant management). Due to the unpredictable nature of preeclampsia, expectant management places mother and child at significant risk until delivery occurs. Eculizumab may be an improvement over current standard of care as it provides a treatment option for patients who would otherwise be managed with expectant management alone. If the study aims are achieved, eculizumab will emerge as an effective treatment option for women with preeclampsia.

Conditions

• Preeclampsia
• Severe Preeclampsia
• Eculizumab
• HELLP
• HELLP Syndrome
• HELLP Syndrome Second Trimester
• Pregnancy Related
• AHUS
• PNH
• Complement Regulatory Factor Defect
• Complement Abnormality
• HELLP Syndrome Third Trimester

Interventions

Type	Name	Description
DRUG	Eculizumab	Eculizumab Intravenous Solution

Timeline

• Start date: 2021-09-13
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2021-01-27
• Last updated: 2023-11-29
• Results posted: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study