A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Trial Parameters
Brief Summary
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Eligibility Criteria
Inclusion Criteria: * Age: 18 to 75 years * A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines * ALP \>1.5 times the ULN at screening * PSC with or without IBD, such as ulcerative colitis or Crohn's disease * If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout the study * If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg/kg/day) for \>3 months prior to screening * Patient agrees to stop all probiotics for at least 2weeks prior to treatment * Patient is unable to conceive and/or patient who's partner is unable to become pregnant and/or agree to use effective methods of contraception when engaging in heterose