Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00432627
First received: February 7, 2007
Last updated: November 2, 2011
Last verified: November 2011

February 7, 2007
November 2, 2011
December 2006
August 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of deferasirox and its metabolites [ Time Frame: at FPFV and at LPLV ] [ Designated as safety issue: No ]
Pharmacokinetics of deferasirox and its metabolites
Complete list of historical versions of study NCT00432627 on ClinicalTrials.gov Archive Site
Safety and tolerability of deferasirox assessed by adverse events [ Time Frame: at FPFV and at LPLV ] [ Designated as safety issue: No ]
Safety and tolerability of deferasirox assessed by adverse events
Not Provided
Not Provided
 
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatic Impairment
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Name: ICL670
  • Experimental: Mild hepatic impaired
    Intervention: Drug: Deferasirox
  • Experimental: Moderate hepatic impaired
    Intervention: Drug: Deferasirox
  • Experimental: Severe hepatic impaired
    Intervention: Drug: Deferasirox
  • Experimental: Healthy volunteers
    Controlled group
    Intervention: Drug: Deferasirox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
August 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00432627
CICL670A2125
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP