Observation of Patients With Transfusional Hemosiderosis... | NCT01394029

Studies
Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

NCT01394029

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Feb 2, 2016Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Transfusional Hemosiderosis

Interventions

deferasirox

Countries

Egypt
Jordan
Spain
United Kingdom

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

Feb 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

Jul 2011

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jul 12, 2011

First Submission Date that Met QC Criteria

Jul 13, 2011

First Posted Date

Jul 14, 2011Estimated

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

Feb 1, 2016

Last Update Posted Date

Feb 2, 2016Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
deferasirox			Drug: deferasirox

Name	Type	Description	Arm Group Labels	Other Names
deferasirox	Drug		deferasirox	ICL670

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Creatinine and liver enzyme levels	Observed over 3 years for each patient	3 years
Adverse Drug Reactions	Observed over 3 years for each patient	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion Criteria:

Patients with non-transfusional hemosiderosis
Patients treated with deferasirox in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

Sampling Method

Non-Probability Sample

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		Cairo	Cairo Governorate	11566	Egypt
Novartis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D019190	Iron Overload

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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