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Pyridoxine in primary sclerosing cholangitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505155-47-00
Acronym
1.1
Enrollment
26
Registered
2023-11-16
Start date
2024-06-19
Completion date
Unknown
Last updated
2023-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary sclerosing cholangitis

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

DRUGEncapsulated tablets of inactive ingredients
DRUG-

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in mean change of alkaline phosphatase (ALP) between the 12-week pyridoxine phase and the 12-week placebo phase

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026