Beta-Thalassemia Clinical Trial
Official title:
A Phase 2b, Double-blind, Randomised, Placebo-controlled, Multicentre Study to Assess the Efficacy and Safety of VIT-2763 Multiple Doses in Adults With Transfusion-dependent Beta-thalassaemia
The main purpose of this study is to evaluate the efficacy of 3 multiple doses of VIT-2763 as measured by the reduction in red blood cell (RBC) transfusion burden from Week 13 to Week 24, to identify the most efficacious and safe dose.
All patients giving written informed consent will undergo a 12-week screening period to determine eligibility for study entry. At Day 1, patients who meet the eligibility requirements will be randomized in a double-blind manner to 1 of 4 treatment groups: VIT-2763 60 mg (once daily), 60 mg (twice daily), or 120 mg (twice daily) or placebo. The randomisation will be stratified (balanced allocation across treatment groups) according to β0/β0 genotype (yes/no). The duration of the treatment with VIT-2763 or placebo is 24 weeks, after which patients will undergo a 12-week post-treatment follow-up period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00069862 -
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00733811 -
Efficacy Study of the Use of Sequential DFP-DFO Versus DFP
|
Phase 4 | |
| Completed |
NCT05506358 -
Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada
|
N/A | |
| Active, not recruiting |
NCT03655678 -
A Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent β-Thalassemia
|
Phase 2/Phase 3 | |
| Completed |
NCT06239389 -
Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.
|
Phase 2 | |
| Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
| Completed |
NCT03271541 -
A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia
|
Phase 2 | |
| Terminated |
NCT02274233 -
Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
|
Phase 1 | |
| Completed |
NCT01206075 -
Evaluating the Safety and Effectiveness of Mozobil Mobilization in Adults With Beta-Thalassemia Major
|
N/A | |
| Recruiting |
NCT05567458 -
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.
|
Phase 2 | |
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Completed |
NCT03961828 -
Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus
|
Phase 4 | |
| Recruiting |
NCT06065189 -
Base-edited Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With β-thalassemia Major
|
Early Phase 1 | |
| Recruiting |
NCT04143724 -
Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia
|
Phase 2 | |
| Terminated |
NCT03381833 -
A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia
|
Phase 2 | |
| Not yet recruiting |
NCT01996683 -
Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
|
N/A | |
| Completed |
NCT02268409 -
ACE-536 Extension Study - Beta Thalassemia
|
Phase 2 | |
| Active, not recruiting |
NCT01016093 -
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT01039636 -
Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload
|
Phase 1 | |
| Withdrawn |
NCT01927913 -
Treatment of Iron Overload Requiring Chelation Therapy
|
Phase 2 |