Efficacy and Safety of Desferal Versus Osveral in Transfu... | NCT01369719

Studies
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

NCT01369719

Sponsor

Hormozgan University of Medical Sciences

Status

Completed

Last Update Posted

Jun 14, 2011Estimated

Enrollment

138Actual

Phase

Not Applicable

Conditions

Thalassemia
Iron Overload
Transfusion Related Complications

Interventions

osveral
Desferal

Countries

Iran

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

Jan 2010

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

Feb 2010

Primary Completion Date

Jan 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jun 6, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 9, 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

Jun 13, 2011

Last Update Posted Date

Jun 14, 2011Estimated

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

Description Module

Brief Summary

Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

Detailed Description

This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Osveral	Experimental	20 mg/kg oral osveral daily	Drug: osveral
desferal	Active Comparator	40mg/kg desferal for 6 nights in a week subcutaneously	Drug: Desferal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
osveral	Drug	receive 20 mg/kg daily orally	Osveral	deferasirox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ferritin level	ferritin level in months 4 and 8 of the study	8 months

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin level	hemoglobin level at months 4 and 8 off the study.	8 month
Drug side effects	Leuckopenia, thrombocytopenia	8 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed intermedia or major thalassemia
More then 2 years old
Serum Ferritin level > 1000
Normal Creatinine and Complete Blood Count (CBC)

Exclusion Criteria:

HCV, HBV or HIV positive patients

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fariba Mansoori, Resident	Hormozgan University of Medical Sciences (HUMS)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hormozgan University of Medical Sciences (HUMS)		Bandar Abbas	Hormozgan	79145-3388	Iran

Condition Browse Module

MeSH Terms

ID	Term
D013789	Thalassemia
D019190	Iron Overload

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077588	Deferasirox
D003676	Deferoxamine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided