Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01369719 |
Recruitment Status :
Completed
First Posted : June 9, 2011
Last Update Posted : June 14, 2011
|
Sponsor:
Hormozgan University of Medical Sciences
Information provided by:
Hormozgan University of Medical Sciences
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | June 6, 2011 | |||
First Posted Date ICMJE | June 9, 2011 | |||
Last Update Posted Date | June 14, 2011 | |||
Study Start Date ICMJE | February 2010 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Ferritin level [ Time Frame: 8 months ] ferritin level in months 4 and 8 of the study
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload | |||
Official Title ICMJE | Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
138 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Iran, Islamic Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01369719 | |||
Other Study ID Numbers ICMJE | Desferal versus Osveral | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS) | |||
Study Sponsor ICMJE | Hormozgan University of Medical Sciences | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Hormozgan University of Medical Sciences | |||
Verification Date | January 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |