Primary sclerosing cholangitis
Conditions
Brief summary
Difference in mean change of alkaline phosphatase (ALP) between the 12-week pyridoxine phase and the 12-week placebo phase
Detailed description
Difference in mean change in PLP levels and HKratio between the 12-week pyridoxine phase and the 12-week placebo phase, Changes in ALAT, ASAT, GGT, total bilirubin between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in the Enhanced Liver Fibrosis test (ELF) between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in interleukin-8 and neopterin between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in PSC-specific revised Mayo risk score; the Amsterdam-Oxford model (AOM); PREsTo; between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in SF-36 Physical summary scale and Mental summary scale between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change of fatigue, evaluated by the Fatigue Impact Scale (FIS) fatigue and a fatigue numerical rating scale (NRS) between the 12-week pyridoxine phase and the 12-week, Difference in mean change of a pruritus numerical rating scale (NRS) between the 12-week pyridoxine phase and the 12-week placebo phase, Number of adverse events and serious adverse advents during the study period, Change in PLP levels and HKratio after open label treatment 12 weeks of 40 mg pyridoxine and 12 weeks of 1.6 mg pyridoxine, Change in alkaline phosphatase levels after open label treatment 12 weeks of 40 mg pyridoxine and 12 weeks of 1.6 mg pyridoxine
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean change of alkaline phosphatase (ALP) between the 12-week pyridoxine phase and the 12-week placebo phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mean change in PLP levels and HKratio between the 12-week pyridoxine phase and the 12-week placebo phase, Changes in ALAT, ASAT, GGT, total bilirubin between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in the Enhanced Liver Fibrosis test (ELF) between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in interleukin-8 and neopterin between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in PSC-specific revised Mayo risk score; the Amsterdam-Oxford model (AOM); PREsTo; between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change in SF-36 Physical summary scale and Mental summary scale between the 12-week pyridoxine phase and the 12-week placebo phase, Difference in mean change of fatigue, evaluated by the Fatigue Impact Scale (FIS) fatigue and a fatigue numerical rating scale (NRS) between the 12-week pyridoxine phase and the 1 | — |
Countries
Norway