NCT01976104

Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure

A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will consist of 3 phases: Prerandomization, Randomization, and a Follow-up Phase. The Prerandomization Phase includes one Screening Visit that will take place from Day -14 through Day -1; the Randomization Phase includes the Baseline Period, Treatment Period, and Procedure Day Period (5 to 8 days after last dose of study drug \[Study Day 10 to 13\]). The Follow-up Phase comprises 2 visits: 7 days post Procedure Day and 30 days after receiving the last dose of study drug. Permitted procedures include: Paracentesis; Thoracentesis; Gastrointestinal endoscopy with or without plans for biopsy, colonoscopy, polypectomy, or variceal banding; Liver biopsy; Bronchoscopy with or without plans for biopsy; Ethanol ablation therapy or chemoembolization for HCC; Vascular catheterization (including right side procedures in participants with pulmonary hypertension); Transjugular intrahepatic portosystemic shunt; Dental procedures; Renal biopsy; Biliary interventions; Nephrostomy tube placement; Radiofrequency ablation; and Laparoscopic interventions.

Conditions

• Thrombocytopenia Associated With Liver Disease

Interventions

Type	Name	Description
DRUG	avatrombopag (lower baseline platelet count)	60 mg avatrombopag (3 x 20 mg tablets)
DRUG	placebo (lower baseline platelet count)	60 mg placebo (3 x 20 mg matching placebo tablets)
DRUG	avatrombopag (higher baseline platelet count)	40 mg avatrombopag (2 x 20 mg tablets)
DRUG	placebo (higher baseline platelet count)	40 mg placebo (2 x 20 mg matching placebo tablets)

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-01-30
• Completion: 2017-02-21
• First posted: 2013-11-05
• Last updated: 2018-02-27
• Results posted: 2018-02-27

Locations

120 sites across 17 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Mexico, Romania, Russia, Spain