Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

Novartis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Deferasirox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432627

CICL670A2125

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Mild hepatic impaired

Experimental group

Treatment:

Drug: Deferasirox

Moderate hepatic impaired

Experimental group

Treatment:

Drug: Deferasirox

Severe hepatic impaired

Experimental group

Treatment:

Drug: Deferasirox

Healthy volunteers

Experimental group

Description:

Controlled group

Treatment:

Drug: Deferasirox