NCT00914927

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia Related to Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	Avatrombopag	Avatrombopag first Dose 80 mg followed by 10 mg a day for up to 6 additional days
DRUG	Avatrombopag	Avatrombopag first Dose 80 mg followed by 20 mg a day for 3 days and then Placebo for 3 additional days
DRUG	Placebo	Placebo or inactive substance once a day for up to 7 days

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-11-11
• Completion: 2011-12-21
• First posted: 2009-06-05
• Last updated: 2018-01-23
• Results posted: 2018-01-23

Locations

1 site across 1 country: United States