The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary sclerosing cholangitis(PSC). * Part 1 will evaluate safety and tolerability of 2 pre-selected dose level of LB-P8 (low-dose\[1×10\^10 CFU/capsule\] and high dose \[1×10\^11 CFU/capsule\]) in adult patients with PSC. Part 1 plans to enroll a maximum number of 12 patients based on a "3+3" study design. * Part 2 will evaluate safety and efficacy in adult patients with PSC. Eligible patients with PSC will be randomized in a 1:1:1 ratio to receive treatment with low-dose LB-P8(1×10\^10 CFU/capsule), high-dose LB-P8(1×10\^11 CFU/capsule) or matched placebo capsule. Part 2 plans to enroll and randomize 75 patients to obtain 60 evaluable patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
87
One capsule QD (1×10\^10 CFU/day) oral administration
One capsule QD (1×10\^11 CFU/day) oral administration
One capsule QD oral administration
University of California Davis
Sacramento, California, United States
NOT_YET_RECRUITINGUCHealth University of Colorado Hospital
Aurora, Colorado, United States
NOT_YET_RECRUITINGUniversity Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Safety and tolerability of 2 different doses of LB-P8
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
Time frame: (Part 1) Up to 4 weeks of treatment from the Baseline
Safety and tolerability of LB-P8
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in ALP
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Percentage of patients who achieve ALP of <1.5 × upper limit of normal (ULN)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in enhanced liver fibrosis (ELF™)
Hyaluronic acid, procollagen-3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1 will be assessed in blood for ELF test.
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Changes from baseline in biliary metrics (biliary strictures and dilatations)
Biliary metrics (biliary strictures and dilatations) will be assessed by magnetic resonance cholangiopancreatography (MRCP)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
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Mercy Medical Center
Baltimore, Maryland, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
NOT_YET_RECRUITINGThe Vanderbilt Clinic
Nashville, Tennessee, United States
RECRUITINGLiver institute Northwest
Seattle, Washington, United States
RECRUITINGChanges from baseline in liver stiffness
Liver stiffness will be measured by transient elastography (FibroScan®)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in alanine aminotransferase (ALT)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in aspartate aminotransferase (AST)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in gamma glutamyl transferase (GGT)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in prothrombin time (PT) and partial prothrombin time (PTT)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in international normalized ratio (INR)
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in total and direct bilirubin
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in fasting serum bile acid level
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline
The percentage of patients who experience liver disease progression
The percentage of patients who experience progression to cirrhosis, clinical decompensation rates, liver transplant, newly diagnosed cholangiocarcinoma, MELD score increase from \<12 to \>15 and Death from any cause
Time frame: (Part 2) Up to 24 weeks of treatment from the Baseline