ThalassemiaNCT01369719
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
A study testing osveral and Desferal in people with Thalassemia and Iron Overload, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Thalassemia, Iron Overload, Transfusion Related Complications
- What is being tested?
- osveral and Desferal
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed intermedia or major thalassemia
- More then 2 years old
- Serum Ferritin level > 1000
- Normal Creatinine and Complete Blood Count (CBC)
Who cannot join
- HCV, HBV or HIV positive patients
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences (HUMS)
Bandar Abbas, Hormozgan, 79145-3388
About this study
Official title: Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
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.
- Being tested
- osveral, Desferal
- Keywords
- Thalassemia, Iron overload, transfusion, osveral, desferal
- Medical subject headings
- Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osveralDrug
Also called deferasirox
receive 20 mg/kg daily orally
DesferalDrug
Also called Deferoxamine
40-50mg/Kg for 6 nights in each week subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Osveral | Experimental | 20 mg/kg oral osveral daily Receives: Drug: osveral |
| desferal | Active comparator | 40mg/kg desferal for 6 nights in a week subcutaneously Receives: Drug: Desferal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin level
ferritin level in months 4 and 8 of the study
Measured: 8 months
Secondary outcomes (2)
Hemoglobin level
hemoglobin level at months 4 and 8 off the study.
Measured: 8 month
Drug side effects
Leuckopenia, thrombocytopenia
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Fariba Mansoori, Resident, Principal investigator, Hormozgan University of Medical Sciences (HUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369719
- Sponsor's protocol ID
- Desferal versus Osveral
- Status last verified
- Jan 2010
- First submitted
- 6 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
- ClinicalTrials.gov ID
- NCT01369719
- Acronym / sponsor ID
- Desferal versus Osveral
- Keywords
- Thalassemia, Iron overload, transfusion, osveral, desferal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osveral | Experimental | Drug: osveral20 mg/kg oral osveral daily |
| desferal | Active comparator | Drug: Desferal40mg/kg desferal for 6 nights in a week subcutaneously |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed intermedia or major thalassemia
- More then 2 years old
- Serum Ferritin level > 1000
- Normal Creatinine and Complete Blood Count (CBC)
Key exclusion criteria (1 listed)
- HCV, HBV or HIV positive patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osveralAlso: deferasiroxreceive 20 mg/kg daily orally | Drug | Osveral |
| DesferalAlso: Deferoxamine40-50mg/Kg for 6 nights in each week subcutaneously | Drug | desferal |
Primary outcome
Ferritin level
Time frame: 8 months
ferritin level in months 4 and 8 of the study
2 secondary outcomes
Hemoglobin level
Time frame: 8 month
Drug side effects
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fariba Mansoori, Resident principal investigator
Hormozgan University of Medical Sciences (HUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osveral and Desferal in people with Thalassemia and Iron Overload, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin level (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.