Table 3 Study assessments
Parameter | Assessment | Timing |
|---|---|---|
Histologic staging of fibrosis | Liver biopsy | Screening and Week 96 (or ET) during blinded phase |
Liver biochemistry | ALP, GGT, ALT, AST, bilirubin, albumin, and INR | Screening, baseline, and Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 (or ET) during blinded phase; OLE baseline, and Weeks 4, 24, 48, 72, and 96 (or ET) |
Clinical liver assessments | Ascites, hepatic encephalopathy, calculation of MELD and CP scores | |
Markers of bile acid homeostasis | Serum bile acids | Screening, baseline, and Weeks 4, 12, 24, 48, 72, and 96 (or ET) during blinded phase; OLE baseline, and Weeks 48 and 96 (or ET) |
Noninvasive markers of liver fibrosis | Liver stiffness by FibroScan | Screening and every 24 weeks (or ET) during blinded phase; OLE baseline and every 24 weeks (or ET) |
ELF | Screening, baseline, and Weeks 4, 12, 24, 48, 72, and 96 (or ET) during blinded phase; OLE baseline, and Weeks 48 and 96 (or ET) | |
Biliary strictures | MRCP | Baseline, and Weeks 48 and 96 (or ET) during blinded phase |
Health resource utilization and HRQOL | SIBDQ (for patients with history of IBD), CLDQ, EQ-5D,a and PSC-PRO | Baseline and every 24 weeks (or ET) during blinded phase; OLE baseline and every 24 weeks (or ET) |
Safety | AEs, clinical laboratory tests, vital sign assessments, and concomitant medications | Various time points throughout study |