Home » Trials » SLCTR/2023/010
Efficacy and safety of deferoxamine, deferasirox, and deferiprone triple iron chelator combination therapy for transfusion-dependent beta-thalassaemia with very high iron overload
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SLCTR Registration Number
SLCTR/2023/010
Date of Registration
The date of last modification
Apr 19, 2023
Scientific Title of Trial
Efficacy and safety of deferoxamine, deferasirox, and deferiprone triple iron chelator combination therapy for transfusion-dependent beta-thalassaemia with very high iron overload
Public Title of Trial
Efficacy and safety of triple iron chelator (deferoxamine, deferasirox, and deferiprone) versus dual iron chelator (deferoxamine and deferasirox) combination therapy for reducing iron overload in transfusion-dependent beta-thalassaemia with very high iron overload.
Disease or Health Condition(s) Studied
Thalassaemia
Scientific Acronym
Public Acronym
Brief title
Triple iron chelator combination therapy for beta-thalassaemia
Universal Trial Number
U1111-1289-8768
Any other number(s) assigned to the trial and issuing authority
P/06/02/2023; ERC, Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
Is the combination treatment with deferoxamine, deferasirox and deferiprone efficacious and safe in iron chelation in patients with transfusion-dependent beta thalassaemia with very high serum ferritin compared to deferasirox and deferoxamine?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
Patients with transfusion-dependent beta-thalassemia major with very high serum ferritin (>3500ng/mL) attending the Adult and Adolescent Thalassaemia Center of the Colombo North Teaching Hospital, Ragama, Sri Lanka, will be randomised into two groups using an online simple randomisation tool for an allocation ratio of 2:1 to intervention and control arms.
The intervention arm will receive combination of oral deferasirox 40mg/kg/day + deferiprone 75mg/kg/day + deferoxamine 25-40mg/kg/day at least 5 days a week for a total of 6 months
The control arm will receive combination of oral deferasirox 40mg/kg/day + deferoxamine 25-40mg/kg/day at least 5 days a week for a total of 6 months
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Reduction in iron overload, as measured by a reduction in the serum ferritin concentration after completion of the treatment. |
[ Baseline, after completion of 6-month treatment ] |
Secondary outcome(s)
|
1.
Reduction in liver iron content as measured by T2* MRI of the liver |
[ Baseline, after completion of 6-month treatment ] |
|
2.
Reduction in cardiac iron content as measured by T2* MRI of the heart |
[ Baseline, after completion of 6-month treatment ] |
|
3.
Side effects of trial medication |
[ After completion of 6-month treatment ] |
Target number/sample size
18 (Intervention arm-12, control arm-6)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-05-01
Anticipated end date
2024-05-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not required
Status
Approved
Date of Approval
2023-02-01
Approval number
P/06/02/2023
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya |
| Institutional Address: | Faculty of Medicine Thalagolla Road Ragama |
| Telephone: | +94112961116 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof Anuja Premawardhena
Professor in Medicine
Department of Medicine
Faculty of Medicine
Thalagolla Road
Ragama
+94112961000
+94716803559
+94112958337
premawa@hotmail.com
Contact Person for Public Queries
Prof Anuja Premawardhena
Professor in Medicine
Department of Medicine
Faculty of Medicine
Thalagolla Road
Ragama
+94112961000
+94716803559
+94112958337
premawa@hotmail.com
Primary study sponsor/organization
Prof Anuja Premawardhena
Professor in Medicine
Department of Medicine
Faculty of Medicine
Thalagolla Road
Ragama
+94112961000
+94112958337
premawa@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
version 1 dated 07.01.2023
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
