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

NCT01976104 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2018-02-27

Study results available
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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).

Conditions

  • Thrombocytopenia Associated With Liver Disease

Interventions

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)

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-01-30
Completion
2017-02-21

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Romania
  • Russia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976104 on ClinicalTrials.gov