Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03420768 | A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C | PHASE2 | COMPLETED | 61 | — | — | Feb 14, 2018 | May 28, 2019 | Feb 4, 2022 | 1 | United States |
The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis
| Arm | Type | Description |
|---|---|---|
| Part 1 BMS-986263 45mg weekly | EXPERIMENTAL | - |
| Part 1 BMS-986263 90mg weekly | EXPERIMENTAL | - |
| Part 1 Placebo weekly | PLACEBO_COMPARATOR | - |
| Part 2 BMS-986263 45mg every 2 weeks | EXPERIMENTAL | - |
| Part 2 BMS-986263 90mg every 2 weeks | EXPERIMENTAL | - |
| Part 2 BMS-986263 90mg every 4 weeks | EXPERIMENTAL | - |
| Part 2 Placebo every 2 weeks | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-986263 | DRUG | Administered by intravenous (IV) infusion |
| Placebo | OTHER | Administered by intravenous (IV) infusion |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is de...