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
The purpose of this study is to evaluate the efficacy of once-daily Oral E5501 in subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of E5501 and to evaluate the pharmacokinetics (PK) of E5501.
Stanford is now accepting new patients for this trial.
- drug : Placebo
- drug : E5501
Phase: Phase 2
Ages Eligible For Study:
1. Males or females ? 18 years of age 2. Thrombocytopenia (defined as a platelet count ? 10,000 - ? 50,000 (+15%)/mm3) 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 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 5. Subjects who are scheduled to undergo an elective invasive procedure between 1 to 4 days post last dose of study drug. 6. Adequate renal function as evidenced by a calculated creatinine clearance ?50 mL/minute per the Cockcroft and Gault formula 7. Life expectancy ?3 months Key