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临床试验/NCT01976104
NCT01976104已完成3 期

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

Eisai Inc.0 个研究点目标入组 204 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Eisai Inc.
入组人数
204
主要终点
Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group A (avatrombopag, lower baseline platelet count)

Experimental

60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5

干预措施: avatrombopag (lower baseline platelet count) (Drug)

Group B (placebo, lower baseline platelet count)

Placebo Comparator

placebo (3 x 20 mg matching placebo tablets) once daily on Days 1 through 5

干预措施: placebo (lower baseline platelet count) (Drug)

Group C (avatrombopag, higher baseline platelet count)

Experimental

40 mg avatrombopag (2 x 20 mg tablets) once daily on Days 1 through 5

干预措施: avatrombopag (higher baseline platelet count) (Drug)

Group D (placebo, higher baseline platelet count)

Placebo Comparator

placebo (2 x 20 mg matching placebo tablets) once daily on Days 1 through 5

干预措施: placebo (higher baseline platelet count) (Drug)

结局指标

主要结局

Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure

时间窗: Randomization (Visit 2), up to 7 Days following a scheduled procedure

Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).

次要结局

  • Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day(Day 10 to Day 13 (Visit 4))
  • Change From Baseline in Platelet Counts on Scheduled Procedure Day(Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4))

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

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