Impact of Hepatic Impairment on the Pharmacokinetics of D... | NCT00432627

Studies
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

NCT00432627

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Hepatic Impairment

Interventions

Deferasirox

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 7, 2007

First Submission Date that Met QC Criteria

Feb 7, 2007

First Posted Date

Feb 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2020

Last Update Posted Date

Dec 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild hepatic impaired	Experimental		Drug: Deferasirox
Moderate hepatic impaired	Experimental		Drug: Deferasirox
Severe hepatic impaired	Experimental		Drug: Deferasirox
Healthy volunteers	Experimental	Controlled group	Drug: Deferasirox

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deferasirox	Drug	one dose of 20 mg/kg/day	Healthy volunteers Mild hepatic impaired Moderate hepatic impaired Severe hepatic impaired

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of deferasirox and its metabolites		at FPFV and at LPLV

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of deferasirox assessed by adverse events		at FPFV and at LPLV

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

Label	URL
Results can be found for CICL670A2125 on the Novartis Clinical Trial Results Website	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000077588	Deferasirox

Ancestor Terms

ID	Term
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided