Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure
Summary
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).
Timeline
- Start
- 2014-02
- Primary completion
- 2017-01-26
- Completion
- 2017-02-27
Outcome
Met primary endpoint
registry analysis (superiority test); 60 mg Placebo (Lower Baseline Platelet Count) vs 60 mg Avatrombopag, (Lower Baseline Platelet Count); p <0.0001 NCT01972529 ↗
registry Difference of proportion vs placebo 42.6 (95% CI 27.2 to 58.1) NCT01972529 ↗
registry analysis (superiority test); 40 mg Placebo (Higher Baseline Platelet Count) vs 40 mg Avatrombopag (Higher Baseline Platelet Count); p <0.0001 NCT01972529 ↗
registry Difference of proportion vs placebo 49.9 (95% CI 31.6 to 68.2) NCT01972529 ↗
Publications
- Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.
- Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avatrombopag | Small molecule | 40 mg | Oral |
| Subject | Avatrombopag | Small molecule | 60 mg | Oral |