Trial · NCT04725812
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Serum Creatinine Before and After Each Treatment. | 24 months | Differences in the concentration of serum creatinine will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Urine Protein Concentration Before and After Each Treatment. | 24 months | Differences in urine protein concentration will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Ratio of Urine Protein to Urine Creatinine Before and After Each Treatment. | 24 months | Differences in the ratio of urine protein concentration to urine creatinine concentration will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Serum Concentration of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Before and After Each Treatment. | 24 months | Differences in the concentration of soluble fms-like tyrosine kinase 1 (sFlt-1) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Serum Concentration of Placental Growth Factor (PlGF) Before and After Each Treatment. | 24 months | Differences in the concentration of placental growth factor (PlGF) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Serum Ratio of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Concentration to Placental Growth Factor (PlGF) Concentration (sFlt-1/PlGF) Before and After Each Treatment. | 24 months | Differences in the serum ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) concentration to placental growth factor (PlGF) concentration (sFlt-1/PlGF) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab. |
| Secondary | Serious Adverse Events | 24 months | Assessment of serious adverse events in eculizumab treatment arm compared with historical controls. 1. Neisseria meningitidis infection or development of invasive meningococcal disease, Neisseria gonorrhoeae, Neisseria sicca/subflava, and Neisseria spp unspecified and Aspergillus infections. 2. Graded clinical and laboratory abnormalities, according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS; DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. \[July 2017\]. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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