Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
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An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion criteria for those with hepatic impairment:
Physical signs consistent with a clinical diagnosis of liver cirrhosis
Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
Otherwise considered healthy
Inclusion criteria for healthy volunteers:
• In good health.
Exclusion criteria for those with hepatic impairment:
Clinically significant abnormal findings other than hepatic impairment
Clinical evidence of severe ascites
History of surgical portosystemic shunt
Any evidence of progressive liver disease within the last 4 weeks
Exclusion criteria for healthy controls:
Clinical evidence of liver disease or liver injury
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
Use of any prescription medication within 1 month prior to dosing
Other protocol defined inclusion/exclusion criteria may apply.