Trial Outcomes & Findings for Complement Regulation to Undo Systemic Harm in Preeclampsia (NCT NCT04725812)

Results Overview

The difference in mean number of days (latency) from enrollment in the study (or hospital admission for controls) to delivery between participant receiving eculizumab compared to historical controls. * For treatment-arm participants latency is determined from enrollment to delivery. * For historical controls latency is determined from hospital admission (or initial diagnosis for controls hospitalized for other indication) for preeclampsia until delivery. * Subjects and historical controls all defined as women with preeclampsia between 23-30 weeks gestation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

24 months

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Eculizumab 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). Eculizumab: Eculizumab Intravenous Solution
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Eculizumab 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). Eculizumab: Eculizumab Intravenous Solution
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Complement Regulation to Undo Systemic Harm in Preeclampsia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eculizumab n=2 Participants 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). Eculizumab: Eculizumab Intravenous Solution
Age, Continuous	37.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 1 enrolled subject withdrew participation before delivery. A second subject withdrew consent after delivery. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects. Historical controls were not identified for this terminated study, thus this Outcome Measure cannot be reported.

The difference in mean number of days (latency) from enrollment in the study (or hospital admission for controls) to delivery between participant receiving eculizumab compared to historical controls. * For treatment-arm participants latency is determined from enrollment to delivery. * For historical controls latency is determined from hospital admission (or initial diagnosis for controls hospitalized for other indication) for preeclampsia until delivery. * Subjects and historical controls all defined as women with preeclampsia between 23-30 weeks gestation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: 1 enrolled subject withdrew participation before delivery. A second subject withdrew consent after delivery. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects. Historical controls were not identified for this terminated study, thus this Outcome Measure cannot be reported.

The difference in the composite number of adverse maternal outcomes between subjects receiving eculizumab compared to historical controls •Adverse maternal outcomes directly attributed to preeclampsia defined as the following: syndrome of hemolysis, elevated liver enzyme, and low platelet count (HELLP), eclampsia, placental abruption, stroke, venous thrombosis or pulmonary embolism, pulmonary edema, posterior reversible encephalopathy syndrome, postpartum hemorrhage (\>1000 cc), blood transfusion, admission to the intensive care unit, acute kidney injury, acute tubular necrosis, dialysis, or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: 1 enrolled subject withdrew participation before delivery. A second subject withdrew consent after delivery. 1 subject's neonate died due to extreme prematurity, which was unrelated to receiving the study drug. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects. Historical controls were not identified for this terminated study, thus this Outcome Measure cannot be reported.

The difference in the composite number of adverse neonatal outcomes between subjects receiving eculizumab compared to historical controls. •Adverse neonatal outcomes directly attributable to preeclampsia or indirectly attributable due to preterm delivery due to preeclampsia defined as the following: Respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity, necrotizing enterocolitis, seizure, hypoxic-ischemic encephalopathy, metabolic acidosis, infection, sepsis, previously unrecognized major malformation detected at birth, patent ductus arteriosus requiring indomethacin, or death.