Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490601
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-21
Brief Title:
Long Term Beta Thalassemia Treatment Findings From The Extension Period
Sponsor:
National Institute of Blood and Marrow Transplant NIBMT Pakistan
Organization:
National Institute of Blood and Marrow Transplant NIBMT Pakistan
Study Overview
Official Title:
Long Term Comparison of Combination Therapy Thalidomide and Hydroxyurea vs Thalidomide Alone in Beta Thalassemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Thalidomide
Brief Summary:
The project titled Long Term Beta Thalassemia Treatment Findings From The Extension Period Of Phase 2 Clinical Trial aims to compare the efficacy and safety of combination therapy thalidomide and hydroxyurea versus thalidomide alone The study lasting three years is a Phase 2 single-center open-label interventional study with a sample size of 30 participants aged 8-35 years It includes specific inclusion and exclusion criteria for participant selection Data will be collected through clinical interviews and medical records and analyzed usingStatistical Package for the Social Sciences This project aims to enhance beta thalassemia treatment strategies focusing on reducing transfusion dependency and improving patient quality of life
Detailed Description:
Study titled Long Term Beta Thalassemia Treatment Findings From The Extension Period Of Phase 2 Clinical Trial conducted at the National Institute of Blood Disease Bone Marrow Transplantation NIBD BMT
This study focuses on the long-term comparison of combination therapy thalidomide and hydroxyurea versus thalidomide alone in treating beta thalassemia The objective is to evaluate the efficacy and safety of the combination therapy compared to thalidomide alone with the hypothesis that the combination will be more effective Beta thalassemia is defined as an autosomal recessive disorder affecting beta-globin production influenced by genetic modifiers Key variables include hemoglobin red blood cells leukocyte count reticulocyte count platelets lactate dehydrogenase nucleated red blood cells ferritin bilirubin Serum Glutamate Pyruvate Transaminase creatinine transfusion frequency spleen and liver size hemoglobin subunit beta Homo sapiens human mutation and certain polymorphism in gamma globin gene The study took place at NIBD hospital over three years designed as a Phase 2 single-center two-arm open-label interventional study with a sample size of 30 participants using simple randomized sampling Inclusion criteria are beta thalassemia majorintermediate patients aged 8-35 years while exclusion criteria include patients with liver dysfunction married patients lactating mothers and those with a history of thrombosis and fits Data will be collected through clinical interviews and medical record reviews and analyzed using Statistical Package for the Social Sciences
This study focuses on the long-term comparison of combination therapy thalidomide and hydroxyurea versus thalidomide alone in treating beta thalassemia The objective is to evaluate the efficacy and safety of the combination therapy compared to thalidomide alone with the hypothesis that the combination will be more effective Beta thalassemia is defined as an autosomal recessive disorder affecting beta-globin production influenced by genetic modifiers Key variables include hemoglobin red blood cells leukocyte count reticulocyte count platelets lactate dehydrogenase nucleated red blood cells ferritin bilirubin Serum Glutamate Pyruvate Transaminase creatinine transfusion frequency spleen and liver size hemoglobin subunit beta Homo sapiens human mutation and certain polymorphism in gamma globin gene The study took place at NIBD hospital over three years designed as a Phase 2 single-center two-arm open-label interventional study with a sample size of 30 participants using simple randomized sampling Inclusion criteria are beta thalassemia majorintermediate patients aged 8-35 years while exclusion criteria include patients with liver dysfunction married patients lactating mothers and those with a history of thrombosis and fits Data will be collected through clinical interviews and medical record reviews and analyzed using Statistical Package for the Social Sciences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None