Status:
COMPLETED
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00432627
Start Date
December 1 2006
End Date
August 1 2010
Last Update
December 9 2020
Active Locations (1)
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1
Novartis Investigative Site
Kiel, Germany