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Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Primary Purpose

Thalassemia, Iron Overload, Transfusion Related Complications

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
osveral
Desferal
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thalassemia focused on measuring Thalassemia, Iron overload, transfusion, osveral, desferal

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hormozgan University of Medical Sciences (HUMS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osveral

desferal

Arm Description

20 mg/kg oral osveral daily

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

Outcomes

Primary Outcome Measures

Ferritin level
ferritin level in months 4 and 8 of the study

Secondary Outcome Measures

Hemoglobin level
hemoglobin level at months 4 and 8 off the study.
Drug side effects
Leuckopenia, thrombocytopenia

Full Information

First Posted
June 6, 2011
Last Updated
June 13, 2011
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01369719
Brief Title
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
Official Title
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia, Iron Overload, Transfusion Related Complications
Keywords
Thalassemia, Iron overload, transfusion, osveral, desferal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osveral
Arm Type
Experimental
Arm Description
20 mg/kg oral osveral daily
Arm Title
desferal
Arm Type
Active Comparator
Arm Description
40mg/kg desferal for 6 nights in a week subcutaneously
Intervention Type
Drug
Intervention Name(s)
osveral
Other Intervention Name(s)
deferasirox
Intervention Description
receive 20 mg/kg daily orally
Intervention Type
Drug
Intervention Name(s)
Desferal
Other Intervention Name(s)
Deferoxamine
Intervention Description
40-50mg/Kg for 6 nights in each week subcutaneously
Primary Outcome Measure Information:
Title
Ferritin level
Description
ferritin level in months 4 and 8 of the study
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Hemoglobin level
Description
hemoglobin level at months 4 and 8 off the study.
Time Frame
8 month
Title
Drug side effects
Description
Leuckopenia, thrombocytopenia
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fariba Mansoori, Resident
Organizational Affiliation
Hormozgan University of Medical Sciences (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences (HUMS)
City
Bandar abbas
State/Province
Hormozgan
ZIP/Postal Code
79145-3388
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

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