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NCT00432627 Clinical Trial

Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

Hepatic Impairment Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00432627
Other study ID # CICL670A2125
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2006
Est. completion date August 2010

Study information
Verified date April 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Deferasirox
one dose of 20 mg/kg/day

Locations
Country Name City State
Germany Novartis Investigative Site Kiel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of deferasirox and its metabolites at FPFV and at LPLV
Secondary Safety and tolerability of deferasirox assessed by adverse events at FPFV and at LPLV
See also
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