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OpenTrials
Completed

NCT Number: NCT00432627

Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Kiel, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deferasirox

Drug

one dose of 20 mg/kg/day

Other names: ICL670

Primary outcomes

  1. Pharmacokinetics of deferasirox and its metabolites

    Time frame: at FPFV and at LPLV

Secondary outcomes

  1. Safety and tolerability of deferasirox assessed by adverse events

    Time frame: at FPFV and at LPLV

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2007
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.