Extension Study of Iron Chelation Therapy With Deferasiro... | NCT00379483

Studies
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

NCT00379483

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 19, 2015Estimated

Enrollment

66Actual

Phase

Phase 2

Conditions

Transfusional Iron Overload

Interventions

Deferasirox

Countries

Italy

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

Mar 2015

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

Jul 2002

Primary Completion Date

Apr 2003Actual

Completion Date

Apr 2003Actual

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Sep 20, 2006

First Posted Date

Sep 22, 2006Estimated

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

Mar 18, 2015

Last Update Posted Date

Mar 19, 2015Estimated

Description Module

Brief Summary

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Detailed Description

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Deferasirox

Name	Type	Description	Arm Group Labels	Other Names
Deferasirox	Drug		Arm 1	ICL670

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment		at 3, 4, 5 years

Secondary Outcomes

Measure	Description	Time Frame
Change in liver iron content measured by SQUID, at 3, 4, and 5 years		at 3, 4, 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion Criteria:

Pregnant or breast feeding patients
Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Cagliari			Italy
Novartis Investigative Site

Intervention Browse Module

MeSH Terms

ID	Term
D000077588	Deferasirox

Ancestor Terms

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

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Browse Branches

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