Primary Biliary Cholangitis
Conditions
Keywords
Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Hepatic Impairment, Cirrhosis, Liver
Brief summary
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
Interventions
DRUGBezafibrate 100 mg
One tablet of bezafibrate 100 mg IR once daily
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
One tablet of obeticholic acid 5 mg tablet once daily.
One tablet of obeticholic acid placebo tablet once daily
DRUGBezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Sponsors
Intercept Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A definite or probable diagnosis of PBC * Qualifying ALP and/or bilirubin liver biochemistry values * Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
Exclusion criteria
* History or presence of other concomitant liver diseases * Presence of clinical complications of PBC * History or presence of decompensating events * Current or history of gallbladder disease * If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating * Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening * Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Alkaline Phosphatase (ALP) from Baseline to Week 12 | Baseline, and at Weeks 2, 4, 6, 8, 10 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with normalization rates of alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alanine aminotransferase (AST), total and conjugated bilirubin and lipid panel | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker GGT | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker ALT | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker AST | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in response rates of ≥10 percent, ≥20 percent, ≥30 percent and ≥40 percent reduction and normalization rates of biochemical disease marker ALP | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in lipid panel | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline of the plasma value of 7 alpha (α) hydroxy 4 cholesten-3 one (C4) | Baseline and at Weeks 2, 4, 6, 8, 10, and 12 |
| Change from Baseline of the plasma value of bile acids, in unit of nanograms per milliliter (ng/ml) | Baseline and at Weeks 2, 4, 6, 8, 10, and 12 |
| Change from Baseline in biochemical disease markers, total & conjugated bilirubin | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
Countries
Argentina, Canada, Italy, United States
Outcome results
None listed