VISTAS
Research type
Research Study
Full title
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
IRAS ID
289588
Contact name
Lara Longpre
Contact email
Sponsor organisation
Mirum Pharmaceutical Inc
Eudract number
2020-003027-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 145022
Duration of Study in the UK
4 years, 2 months, 1 days
Research summary
PSC is a progressive inflammatory cholestatic disease characterised by inflammation and fibrosis of the bile ducts and liver. Intense pruritus (itching) can be a debilitating complication of certain cholestatic diseases and is likely a result of high circulating bile acid levels, which can lead to fatigue, social isolation, and a lower quality of life. Intractable pruritus can be the primary indication for liver transplantation. Frequently, PSC is commonly associated with inflammatory bowel disease (IBD). This study is to monitor the efficacy and safety in patients with primary sclerosing cholangitis (PSC).
Male and female participants who are over 18 and have been identified as having or possibly having pruritus (itching) associated with primary sclerosing cholangitis (PSC) are being invited to take part in this study.
This study will be conducted at multiple sites across North America and Europe, with other regions added as necessary.
Participation in the Core Study is expected to last for approximately 32 weeks, including the screening period and Core Study period, with the option to continue into the Open Label Extension for 24 months.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
21/EE/0079
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion