NCT01369719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
Last Updated

June 14, 2011

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

June 6, 2011

Last Update Submit

June 13, 2011

Conditions

ThalassemiaIron OverloadTransfusion Related Complications

Keywords

ThalassemiaIron overloadtransfusionosveraldesferal

Outcome Measures

Primary Outcomes (1)

  • Ferritin level

    ferritin level in months 4 and 8 of the study

    8 months

Secondary Outcomes (2)

  • Hemoglobin level

    8 month

  • Drug side effects

    8 months

Study Arms (2)

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

osveralDRUG

receive 20 mg/kg daily orally

Also known as: deferasirox
Osveral
DesferalDRUG

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

Also known as: Deferoxamine
desferal

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • HCV, HBV or HIV positive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, 79145-3388, Iran

Location

MeSH Terms

Conditions

ThalassemiaIron Overload

Interventions

DeferasiroxDeferoxamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHydroxamic AcidsHydroxylaminesAminesHydroxy Acids

Study Officials

  • Fariba Mansoori, Resident

    Hormozgan University of Medical Sciences (HUMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 9, 2011

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

June 14, 2011

Record last verified: 2010-01

Locations

IR(1)