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Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 7, 2007
Last updated: April 20, 2016
Last verified: April 2016
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.

Condition Intervention Phase
Hepatic Impairment
Drug: Deferasirox
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

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

Enrollment: 24
Study Start Date: December 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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.

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Please refer to this study by its identifier: NCT00432627

Novartis Investigative Site
Kiel, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00432627     History of Changes
Other Study ID Numbers: CICL670A2125
Study First Received: February 7, 2007
Last Updated: April 20, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017