Primary biliary cholangitis
Conditions
Brief summary
The primary efficacy endpoint is the change in ALP from baseline to Week 12 in the DB Phase
Detailed description
Safety and tolerability, The response rates of ≥10%, ≥20%, ≥30%, and ≥40% reduction from baseline at Week 12, and normalization rates of ALP at Week 12, Normalization rates at Week 12 of GGT, ALT, AST, total and conjugated bilirubin, and lipid panel, Change from baseline to Week 12 in GGT, ALT, AST, ALP and total and conjugated bilirubin, and lipid panel, Change from baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4) and bile acids
Interventions
DRUGOcaliva 5 mg film-coated tablets
Sponsors
Intercept Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the change in ALP from baseline to Week 12 in the DB Phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability, The response rates of ≥10%, ≥20%, ≥30%, and ≥40% reduction from baseline at Week 12, and normalization rates of ALP at Week 12, Normalization rates at Week 12 of GGT, ALT, AST, total and conjugated bilirubin, and lipid panel, Change from baseline to Week 12 in GGT, ALT, AST, ALP and total and conjugated bilirubin, and lipid panel, Change from baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4) and bile acids | — |
Countries
Italy
Outcome results
None listed