CClinicalTrials.gg
CompletedNCT01369719Updated Jun 14, 2011

Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

An interventional study of osveral and Desferal in Thalassemia, Iron Overload and Transfusion Related Complications, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2011-06-14.

Sponsored by Hormozgan University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Thalassemia
  • Iron Overload
  • Transfusion Related Complications

Keywords

  • Thalassemia
  • Iron overload
  • transfusion
  • osveral
  • desferal
03

In context

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's enrollment of 138 is above the median of 37 across 277 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • HCV, HBV or HIV positive patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    Osveral

    20 mg/kg oral osveral daily

    Drug: osveral

  • Active comparator
    desferal

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

    Drug: Desferal

Interventions

  • Drugosveral

    receive 20 mg/kg daily orally

    Also known as: deferasirox

  • DrugDesferal

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

    Also known as: Deferoxamine

06

What researchers measure

Primary outcomes

  1. Ferritin level

    ferritin level in months 4 and 8 of the study

    Time frame: 8 months

Secondary outcomes

  1. Hemoglobin level

    hemoglobin level at months 4 and 8 off the study.

    Time frame: 8 month

  2. Drug side effects

    Leuckopenia, thrombocytopenia

    Time frame: 8 months

07

Study locations

1 site
  • Hormozgan University of Medical Sciences (HUMS)
    Bandar abbas, Hormozgan 79145-3388, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01369719
Lead sponsor
Hormozgan University of Medical Sciences
First posted
Jun 9, 2011
Start date
Feb 2010
Primary completion
Jan 2011
Completion
May 2011
Last update
Jun 14, 2011

Study contacts

Fariba Mansoori, Resident
principal investigator · Hormozgan University of Medical Sciences (HUMS)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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