Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics of Once-Daily Oral E5501 Tablets Used Up to 7 Days in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

NCT00914927•Eisai Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag and to evaluate the pharmacokinetics (PK) of E5501.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females ≥ 18 years of age
•2. Thrombocytopenia (defined as a platelet count ≥ 10,000 - ≤ 50,000 (+15%)/mm\^3 )
•3. Model for End-Stage Liver Disease (MELD) scores ≤ 24
•4. Chronic liver diseases due to one of the following three etiologies:
•Chronic Viral Hepatitis from one of the following categories
•* Chronic Hepatitis C (defined as the presence of anti-hepatitis C virus \[HCV\] antibodies and/or detectable serum HCV ribonucleic acid \[RNA\] levels)
•* OR chronic Hepatitis B (defined as the presence of hepatitis B surface antigen \[HBsAg\] and/or detectable serum hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\])
•* OR chronic Hepatitis B and C co-infection (as defined by the above bullet points)
•* OR chronic Hepatitis C and history of alcohol abuse
•* OR chronic Hepatitis B and history of alcohol abuse
+13 more criteria

Exclusion Criteria

•1. Hepatic encephalopathy that cannot be effectively treated.
•2. Platelet transfusion within 7 days prior to the first dose of study drug
•3. Received blood products, eg, FFP and cryoprecipitate 7 days prior to the first dose of study drug
•4. Have surgical or diagnostic procedure scheduled during the Randomization Phase (Day 1 to Day 8) of this study
•5. Interferon use within 2 weeks of Day 1
•6. Hormonal contraceptive use within 60 days of study entry
•7. History of human immunodeficiency virus (HIV) infection
•8. Any prohibited concomitant medications or therapy that cannot be discontinued by Visit 1
•9. Active alcohol abuse, active alcohol dependence syndrome, drug abuse, or drug dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)
•10. Acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within 6 months of the study start
+11 more criteria

Locations (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

November 11, 2011

Completion Date

December 21, 2011

Last Updated

January 23, 2018

Enrollment

130

ACTUAL participants

Conditions

Thrombocytopenia Related to Chronic Liver Disease

Interventions

Avatrombopag

DRUG

Avatrombopag

DRUG

Placebo

DRUG