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A4250 in PBC and Cholestatic Pruritus
NCT02360852Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2015
- Primary completion
- Oct 2016
- Countries
- 1
- Sponsor
- Sahlgrenska University Hospital
- Modality
- Small Molecules
- Drugs
- odevixibat
- Conditions
- primary biliary cholangitis (PBC)cholestatic pruritus
01
Overview
Phase 2, open-label, single-arm trial of odevixibat in primary biliary cholangitis (PBC) and cholestatic pruritus, sponsored by Sahlgrenska University Hospital. Primary endpoint: Treatment-emergent serious adverse events at 4 weeks. Started Jan 2015; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
A4250
A4250 once daily
03
Who it enrols
Adult patients with definite or probable Primary Biliary Cholangitis (PBC) who are non-responders to UDCA and have significant pruritus (VAS-Itch >= 30mm). Patients must have a history of elevated ALP and positive AMA or PBC-specific antibodies. Exclusion criteria include extrahepatic jaundice, GI structural abnormalities, and active infection.
04
Endpoints
Primary
Treatment-emergent serious adverse events
Secondary
Safety laboratory measurements
Visual Analogue Scale for Itch
Itching scale
Bile acid evaluation
Liver biochemistry
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