A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
ConditionPrimary Sclerosing Cholangitis (PSC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLISCure Biosciences
About this trial
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Eligibility criteria
Qualifiers
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
Disqualifiers
Treatment with any investigational agents within 3 months or 5 half-lives, whichever is longer prior to treatment or during the study. Gene therapy or other long-lasting investigational agents with unknown half-life is not allowed
History of a liver transplant or anticipated need for a liver transplant within 1 year
Patients who show evidence of significant worsening of hepatic function will be excluded.
Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters
Trial design
Treatments tested in this trial
- LB-P8 low-dose
- LB-P8 high-dose
- Placebo
Treatment groups
87 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov