Trial · NCT04980248
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 up to Day 85 | TEAEs were defined as any adverse events (AEs) that began or worsened on or after the first dose of treatment until the final follow-up visit. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TESAEs were defined as any serious AEs that began or worsened on or after the first dose of treatment until the final follow-up visit. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of ALXN1850 Following Intravenous (IV) Dose, Subcutaneous (SC) Dose 1, SC Dose 2 and SC Dose 3 | Predose, 2, 6 and 12 hours postdose on Days 1, 15, 22 and 29 | |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity Following IV Dose of ALXN1850 | Predose, 2, 6 and 12 hours postdose on Days 1, 15, 22 and 29 | |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to Dosing Interval (AUCtau) Following SC Dose 1, SC Dose 2 and SC Dose 3 | Predose, 2, 6 and 12 hour postdose on Days 1, 15, 22 and 29 | |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to Dosing Interval (AUCtau) Values of the First SC Versus IV Administration of ALXN1850 | Predose, 2, 6 and 12 hour postdose on Days 1, 15, 22 and 29 | |
| Secondary | Absolute Change From Baseline in Plasma Concentration of Pyridoxal-5' Phosphate (PLP) at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Absolute Change From Baseline in Plasma Concentration of Inorganic Pyrophosphate (PPi) at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Absolute Change From Baseline in Plasma Concentration of Pyridoxal Phosphate/ Pyridoxal (PLP/PL) Ratio at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Percent Change From Baseline in Plasma Concentration of PLP at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Percent Change From Baseline in Plasma Concentration of PPi at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Percent Change From Baseline in Plasma Concentration of PLP/PL Ratio Over Time at Week 1 | Baseline, 1 Week post Day 1 IV dose and 1 Week post Day 29 SC dose 3 | |
| Secondary | Number of Participants With Anti-drug Antibody (ADA) Positive and Neutralizing Antibody (NAb) Positive Status | Baseline up to Day 85 |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04980248/registered