Status:
COMPLETED
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures
Lead Sponsor:
Eisai Inc.
Conditions:
Thrombocytopenia Related to Chronic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, t...
Eligibility Criteria
Inclusion
- Key
- Males or females ≥ 18 years of age
- Thrombocytopenia (defined as a platelet count ≥ 10,000 - ≤ 50,000 (+15%)/mm\^3 )
- Model for End-Stage Liver Disease (MELD) scores ≤ 24
- 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
- NASH diagnosed as:
- absence of serologic evidence of viral hepatitis and
- convincing evidence of a history of minimal or no alcohol consumption, and
- histologic picture of steatohepatitis OR
- when histology is unavailable, then clinical, radiographic and laboratory evidence of NASH
- Alcoholic liver disease diagnosed as:
- absence of serologic evidence of viral hepatitis and
- history of heavy alcohol consumption and
- histologic picture of alcoholic liver disease OR
- when histology is unavailable, then clinical, radiographic and laboratory evidence of hepatitis combined with years of excessive alcohol intake
- Subjects who are scheduled to undergo an elective invasive procedure between 1 to 4 days post last dose of study drug.
- Adequate renal function as evidenced by a calculated creatinine clearance ≥50 mL/minute per the Cockcroft and Gault formula
- Life expectancy ≥3 months
- Key
Exclusion
- Hepatic encephalopathy that cannot be effectively treated.
- Platelet transfusion within 7 days prior to the first dose of study drug
- Received blood products, eg, FFP and cryoprecipitate 7 days prior to the first dose of study drug
- Have surgical or diagnostic procedure scheduled during the Randomization Phase (Day 1 to Day 8) of this study
- Interferon use within 2 weeks of Day 1
- Hormonal contraceptive use within 60 days of study entry
- History of human immunodeficiency virus (HIV) infection
- Any prohibited concomitant medications or therapy that cannot be discontinued by Visit 1
- 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)
- Acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within 6 months of the study start
- History of any primary hematologic disorder
- History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system
- Any evidence of current portal vein thrombosis (PVT) as detected by Doppler sonography or appropriate MRI/CT imaging at Screening and/or within approximately 30 days prior to Screening
- Any acute/active bleeding (gastrointestinal \[GI\], central nervous system \[CNS\], etc)
- Uncompensated congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)
- Pre-diagnosed Immune Thrombocytopenic Purpura (ITP)
- History of Myelodysplastic Syndrome (MDS)
- Females who are pregnant (positive β-hCG test ) or breastfeeding
- Current use of recreational drugs
- Post-transplant patients
- Subjects who have participated in another investigational trial within 30 days prior to Visit 1.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2011
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00914927
Start Date
May 1 2009
End Date
December 21 2011
Last Update
January 23 2018
Active Locations (1)
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1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121