Trial · NCT04725812
Complement Regulation to Undo Systemic Harm in Preeclampsia
NCT04725812, Phase 2, Terminated, Cedars-Sinai Medical Center; results first posted 2023-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Complement Regulation to Undo Systemic Harm in Preeclampsia. Trials, record NCT04725812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04725812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Complement Regulation to Undo Systemic Harm in Preeclampsia
- NCT number
- NCT04725812
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- 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
- Eculizumab
- First posted
- 2021-01-27
- Last updated
- 2023-11-29
- Results first posted
- 2023-11-29
- Limitations and caveats
The PI, Dr. Richard Burwick left the institution where this research was being conducted in April 2022 and study activity halted at that time. Two subjects were consented to participate in the study and one withdrew participation before study procedures were completed. Study Funding was terminated by Sponsor.~Dr. Karumanchi is a co-investigator in this study who has been named as the Responsible Party within the PRS system solely for the purpose of reporting the results.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Latency (in Days) From Enrollment to Delivery | 24 months | 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. |
| Secondary | Composite Adverse Maternal Outcomes | 24 months | 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 |
| Secondary | Composite Adverse Neonatal Outcomes | 24 months | 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. |
| Secondary | Changes in Blood and Urine Concentrations of Terminal Complement Protein C5a Before and After Each Treatment. | 24 months | The Difference in the concentration of C5a in blood and urine, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab. •Concentrations of C5a in blood and urine will be determined by enzyme linked immunosorbent assays (ELISA). |
| Secondary | Changes in Blood and Urine Concentrations of Terminal Complement Protein C5b-9 Before and After Each Treatment. | 24 months | The difference in blood and urine concentrations of C5b-9, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab. |
| Secondary | Changes in Blood and Urine Concentrations of Complement Protein CD59 Before and After Each Treatment. | 24 months | The difference in blood and urine concentrations of CD59, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab. |
| Secondary | Aspartate and Alanine Transaminase Concentration Before and After Each Treatment. | 24 months | Differences in the concentration of aspartate and alanine transaminase (U/L) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Hemoglobin Concentration Before and After Each Treatment. | 24 months | Differences in the concentrations of measures of hemoglobin will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Platelet Count Before and After Each Treatment. | 24 months | Differences in the platelet count will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Lactate Dehydrogenase Concentration Before and After Each Treatment. | 24 months | Differences in the concentration of serum lactate dehydrogenase will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Latency (in Days) From Enrollment to Delivery | 24 months | 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. | ||
| SECONDARY | Composite Adverse Maternal Outcomes | 24 months | 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. | ||
| SECONDARY | Composite Adverse Neonatal Outcomes | 24 months | 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. | ||
| SECONDARY | Changes in Blood and Urine Concentrations of Terminal Complement Protein C5a Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Changes in Blood and Urine Concentrations of Terminal Complement Protein C5b-9 Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Changes in Blood and Urine Concentrations of Complement Protein CD59 Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Aspartate and Alanine Transaminase Concentration Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Hemoglobin Concentration Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Platelet Count Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. | ||
| SECONDARY | Lactate Dehydrogenase Concentration Before and After Each Treatment. | 24 months | Assays for research lab samples were not done as the study was prematurely halted. Data supporting the primary and secondary outcomes were not collected from the two enrolled subjects, thus the data could not be reported. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eculizumab | 2 | |
| Overall Study | COMPLETED | Eculizumab | 1 | |
| Overall Study | NOT COMPLETED | Eculizumab | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Neonatal death | General disorders | Eculizumab | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eculizumab | 1 | 2 |
| Total, other adverse events | Eculizumab | 0 | 2 |
| Total, serious adverse events | Eculizumab | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04725812
GET https://conductscience.org/api/trials/v1/NCT04725812/registered