Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

NCT ID: NCT01369719

Last Updated: 2011-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

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

Conditions

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Thalassemia Iron Overload Transfusion Related Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Osveral

20 mg/kg oral osveral daily

Group Type EXPERIMENTAL

osveral

Intervention Type DRUG

receive 20 mg/kg daily orally

desferal

40mg/kg desferal for 6 nights in a week subcutaneously

Group Type ACTIVE_COMPARATOR

Desferal

Intervention Type DRUG

40-50mg/Kg for 6 nights in each week subcutaneously

Interventions

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osveral

receive 20 mg/kg daily orally

Intervention Type DRUG

Desferal

40-50mg/Kg for 6 nights in each week subcutaneously

Intervention Type DRUG

Other Intervention Names

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deferasirox Deferoxamine

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hormozgan University of Medical Sciences (HUMS)

Principal Investigators

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Fariba Mansoori, Resident

Role: PRINCIPAL_INVESTIGATOR

Hormozgan University of Medical Sciences (HUMS)

Locations

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Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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Desferal versus Osveral

Identifier Type: -

Identifier Source: org_study_id

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