Trial · NCT05478720
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of local AEs occurring within 14 days after the administration of DON | 14 days | Number of AEs |
| Primary | Incidence of systemic AEs occurring within 14 days after the administration of DON | 14 days | Number of AEs |
| Primary | Incidence of systemic SAEs occurring within 14 days after the administration of DON | 14 days | Number of SAEs - pediatric arms only |
| Primary | Assessment of Blantyre Coma Score | 14 days | Time to Blantyre Coma Score of 5 |
| Secondary | PK measurement of DON in sera of recipients measured by half life | Measured through 18 hours post infusion | Measurement of half life |
| Secondary | PK measurement of DON in sera of recipients measured by volume of distribution | Measured through 18 hours post infusion | Measurement of Vd |
| Secondary | PK measurement of DON in sera of recipients measure by maximum concentration (Cmax) | Measured through 18 hours post infusion | Measurement of Cmax |
| Secondary | PK measurement of DON in sera of recipients measure by time of maximal concentration (Tmax) | Measured through 18 hours post infusion | Measurement of Tmax |
| Secondary | PK measurement of DON in sera of recipients measure by area under the concentrations vs. time curve (AUC) | Measured through 18 hours post infusion | Measurement of AUC |
| Secondary | PK measurement of DON in sera of recipients measure by clearance | Measured through 18 hours post infusion | Clearance measured over time |
| Secondary | PK measurement of DON in sera of recipients measure by elimination rate | Measured through 18 hours post infusion | Elimination over time |
| Secondary | PK measurement of DON in sera of recipients measure by terminal T1/2 | Measured through 18 hours post infusion | Measurement of terminal T1/2 |
| Other | Pediatric participants: Brain volume score on MRI at admission and 24 hours (+/- 6 hours) post-randomization, if MRI is available | Measured at baseline and 24 hours post randomization | Detected by MRI |
| Other | Pediatric participants: Number of minutes of electrographic seizures within the first 12 hours after DON administration | Measured through 12 hours post infusion | Detected by continuous EEG monitoring |
| Other | Pediatric participants: EEG power analysis | Measured at baseline and through 12 hours post infusion | Detected by 30 minute EEG samples analyzing power at baseline and 3, 6, and 12 hours post infusion |
| Other | Pediatric participants: EEG amplitude analysis | Measured at baseline and through 12 hours post infusion | Detected by 30 minute EEG samples analyzing amplitude at baseline and 3, 6, and 12 hours post infusion |
| Other | Pediatric participants: EEG frequency analysis | Measured at baseline and through 12 hours post infusion | Detected by 30 minute EEG samples analyzing frequency at baseline and 3, 6, and 12 hours post infusion |
| Other | Pediatric participants: Transcranial Doppler (TCD) phenotype flow velocities | Measured through 24 hours post infusion | Detected by TCD at 4H and 24H post infusion |
| Other | Pediatric participants: Cerebrospinal Fluid Metabolic Profile | Measured through 4 hours post infusion | Detected by LP at baseline and 4H (+ or - 2H) post DON infusion |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05478720/registered