Pateints of β-thalassemia Major With Iron OverloadNCT06468423
Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
A study testing Deferasirox (DFX) and Deferoxamine (DFO) in people with Pateints of β-thalassemia Major With Iron Overload, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Pateints of β-thalassemia Major With Iron Overload
- What is being tested?
- Deferasirox (DFX) and Deferoxamine (DFO)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 30 Sep 2023
- 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
- Iron overload (serum ferritin level above 1000 µg/L)
Who cannot join
- Patients with other transfusion-dependent anemias
- Thalassemia major with cardiomyopathy or arrhythmia.
- Chronic renal failure
- Chronic liver disease (ALT >200 IU)
- Hhypersensitivity to deferasirox or desferrioxamine
- Patients already on combined chelation therapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health
Multan, Punjab Province, 59210
About this study
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.
- Being tested
- Deferasirox (DFX), Deferoxamine (DFO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferasirox (DFX)Drug
Also called Deferasirox
Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.
Deferoxamine (DFO)Drug
Also called Deferoxamine
DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week for a duration of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Deferasirox (DFX) group | Experimental | DFX group (n=71) included children who used oral (tablet) DFX at a dose of 30 mg/kg once daily for a duration of 6 months. Receives: Drug: Deferasirox (DFX) |
| Desferioxamine (DFO) group | Experimental | DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week Receives: Drug: Deferoxamine (DFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Serum Ferritin Levels
Change in mean serum ferritin level from baseline for each group.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pateints of β-thalassemia Major With Iron OverloadStudies 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
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468423
- Sponsor's protocol ID
- RESnTEC
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable resquest to parimary researcher.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
- ClinicalTrials.gov ID
- NCT06468423
- Acronym / sponsor ID
- RESnTEC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Jun 2024 (actual)
- 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.
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferasirox (DFX) group | Experimental | Drug: Deferasirox (DFX)DFX group (n=71) included children who used oral (tablet) DFX at a dose of 30 mg/kg once daily for a duration of 6 months. |
| Desferioxamine (DFO) group | Experimental | Drug: Deferoxamine (DFO)DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
- Iron overload (serum ferritin level above 1000 µg/L)
Key exclusion criteria (6 listed)
- Patients with other transfusion-dependent anemias
- Thalassemia major with cardiomyopathy or arrhythmia.
- Chronic renal failure
- Chronic liver disease (ALT >200 IU)
- Hhypersensitivity to deferasirox or desferrioxamine
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 |
|---|---|---|
| Deferasirox (DFX)Also: DeferasiroxOral DFX at a dose of 30mg/kg daily advised for a duration of 6 months. | Drug | Deferasirox (DFX) group |
| Deferoxamine (DFO)Also: DeferoxamineDFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week for a duration of 6 months. | Drug | Desferioxamine (DFO) group |
Primary outcome
Mean Serum Ferritin Levels
Time frame: 6 months
Change in mean serum ferritin level from baseline for each group.
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 21 Jun 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable resquest to parimary researcher.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deferasirox (DFX) and Deferoxamine (DFO) in people with Pateints of β-thalassemia Major With Iron Overload, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 2 inclusion and 6 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 21 Jun 2024. 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 Pakistan. 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?
Mean Serum Ferritin Levels (time frame: 6 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 21 Jun 2024.