Clinical Trials Logo
  1. Home
  2. Beta-Thalassemia
  3. NCT01039636

Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload

Beta-thalassemia Clinical Trial

Official title:
A PHASE 1b OPEN LABEL, MULTI-CENTER, ESCALATING MULTIPLE DOSE STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF FBS0701 IN PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD

Clinical Trial Summary

The purpose of this research study is to study the safety of increasing doses of FBS0701, and to see how quickly the study medication is absorbed and how quickly it disappears from the bloodstream. FBS0701 is a new, oral iron chelator - a medication taken by mouth that increases the body's elimination of iron. Iron chelators are used in patients who develop iron overload from their transfusions. Four increasing doses of FBS0701 will be tested during this study. The study will start with the lowest dose given to 4 patients (3 mg/kg/day. The next group of 4 patients will receive the next high dose (8mg/kg/day only after the results of the first 4 patients are examined and it is determined safe to continue. Participating patients will take the study medication for 7 days and be followed for 28 days after their last dose to determine if they have any reactions to the study medication - therefore a total of 35 days on study. Patients will need to give up to 17 blood samples over the screening period and first 15 days of the study (a total of about 9 tablespoons). Patients will not need to stay overnight in the clinic but will need to visit the clinic 10 times for screening and on-study visits over the 35 days. Patients currently taking an iron chelator will need to stop that treatment for up to 22 days (up to 5 days before they start the study and for 15 days during the study). The results of this study will be helpful in determining the safety of the drug and the best doses of FBS0701 to be used in the next study which will assess the effectiveness of this new iron chelator.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01039636
Study type Interventional
Source FerroKin BioSciences, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 2009
View Details
See also
  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
Withdrawn NCT04938635 - Efficacy and Safety Study of Multiple Doses of VIT-2763 in Adults With Transfusion-dependent Beta-thalassemia Phase 2
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
Withdrawn NCT01927913 - Treatment of Iron Overload Requiring Chelation Therapy Phase 2