Primary Hyperoxaluria Type 1 (PH1)
Conditions
Brief summary
Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101- related TEAEs and serious adverse events (SAEs)
Detailed description
Percent change in 24-hour urinary oxalate excretion (UOx) from Baseline to Month (CCI), Absolute change in UOx corrected for body surface area, Percent change in plasma glycolate from Baseline to Month (CCI), Changes in estimated glomerular filtration rate (eGFR) from Baseline to Month (CCI) and Month (CCI), Plasma concentrations for (CCI), and (CCI), Urine concentrations for (CCI) and (CCI), Antidrug antibodies to ABO-101 and anti-Cas12i2 protein antibodies
Interventions
DRUGABO-101
Sponsors
Arbor Biotechnologies Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101- related TEAEs and serious adverse events (SAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in 24-hour urinary oxalate excretion (UOx) from Baseline to Month (CCI), Absolute change in UOx corrected for body surface area, Percent change in plasma glycolate from Baseline to Month (CCI), Changes in estimated glomerular filtration rate (eGFR) from Baseline to Month (CCI) and Month (CCI), Plasma concentrations for (CCI), and (CCI), Urine concentrations for (CCI) and (CCI), Antidrug antibodies to ABO-101 and anti-Cas12i2 protein antibodies | — |
Countries
France, Germany, Netherlands
Outcome results
None listed