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
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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:

Primary Outcome Measures:
  • Pharmacokinetics of deferasirox and its metabolites [ Time Frame: at FPFV and at LPLV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of deferasirox assessed by adverse events [ Time Frame: at FPFV and at LPLV ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432627

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00432627     History of Changes
Other Study ID Numbers: CICL670A2125
Study First Received: February 7, 2007
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014