Primary Biliary Cholangitis
Conditions
Brief summary
EFS as measured by the time from start of treatment to the first occurrence of any of the following adjudicated events up to week 156: a. Death by any cause b. Liver transplantation c. MELD Score ≥ 15 d. Ascites requiring treatment e. Hospitalization for any of the following qualifying events: i.Esophageal or gastric variceal bleeding ii.Hepatic encephalopathy iii. Spontaneous bacterial peritonitis
Detailed description
Overall survival, defined as time from start of treatment to death from any cause up to Week 156, LTFS, defined as time from start of treatment to the first occurrence of any of the following up to Week 156: a. Liver-related death b. Liver transplantation, Time to hospitalization for qualifying PBC clinical events from start of treatment up to Week 156:, Time to each of the other adjudicated PBC clinical events from start of treatment up to Week 156: a. MELD Score ≥ 15 b. Ascites requiring treatment
Interventions
DRUGPlacebo to match 5 mg
DRUGPlacebo to match 10 mg
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS as measured by the time from start of treatment to the first occurrence of any of the following adjudicated events up to week 156: a. Death by any cause b. Liver transplantation c. MELD Score ≥ 15 d. Ascites requiring treatment e. Hospitalization for any of the following qualifying events: i.Esophageal or gastric variceal bleeding ii.Hepatic encephalopathy iii. Spontaneous bacterial peritonitis | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, defined as time from start of treatment to death from any cause up to Week 156, LTFS, defined as time from start of treatment to the first occurrence of any of the following up to Week 156: a. Liver-related death b. Liver transplantation, Time to hospitalization for qualifying PBC clinical events from start of treatment up to Week 156:, Time to each of the other adjudicated PBC clinical events from start of treatment up to Week 156: a. MELD Score ≥ 15 b. Ascites requiring treatment | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain
Outcome results
None listed