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Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

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ClinicalTrials.gov Identifier: NCT00432627
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Deferasirox Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Deferasirox
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mild hepatic impaired Drug: Deferasirox
one dose of 20 mg/kg/day
Other Name: ICL670
Experimental: Moderate hepatic impaired Drug: Deferasirox
one dose of 20 mg/kg/day
Other Name: ICL670
Experimental: Severe hepatic impaired Drug: Deferasirox
one dose of 20 mg/kg/day
Other Name: ICL670
Experimental: Healthy volunteers
Controlled group
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Name: ICL670



Primary Outcome Measures :
  1. Pharmacokinetics of deferasirox and its metabolites [ Time Frame: at FPFV and at LPLV ]

Secondary Outcome Measures :
  1. Safety and tolerability of deferasirox assessed by adverse events [ Time Frame: at FPFV and at LPLV ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432627


Locations
Germany
Novartis Investigative Site
Kiel, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00432627     History of Changes
Other Study ID Numbers: CICL670A2125
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hepatic impairment
adults
deferasirox

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action