ISRCTN17052121CompletedPhase 2
A phase 2, 24-week, randomized, open label, multi-center study to assess the safety, tolerability, and pharmacodynamics of FBS0701 in the treatment of chronic iron overload requiring chelation therapy
FerroKin BioSciences Inc. (USA)0 sites40 target enrollmentStarted: September 13, 2010Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age: 18-60 years old at screening
- •2. Transfusional iron overload due to:
- •2.1. Hereditary anemias such as sickle cell disease, ß-thalassemia and Blackfan-Diamond anemia
- •2.2. Acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure
- •3. Patients must also be transfusion-dependent (8 or more transfusions annually) and require chronic treatment with deferoxamine, deferasirox, and/or deferiprone
- •4. Willing to discontinue all existing iron chelation therapies throughout the study period
- •5. Serum ferritin >500 ng/mL at screening
- •6. Baseline liver iron concentration (LIC) and cardiac T2* MRI per protocol requirements
- •7. Mean of the previous three pre-transfusion haemoglobin concentrations = 7.5 g/dL
- •8. Agrees to use an approved method of contraception througout the study
Exclusion Criteria
- •1. As a result of medical review, physical examination or screening investigations, the Principal Investigator considers the patient unfit for the study
- •2. Non-elective hospitalisation within the 30 days prior to baseline testing
- •3. Evidence of clinically relevant oral, cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immunologic, bone marrow or skin disorder as determined by the investigator
- •4. Evidence of significant renal insufficiency
- •5. Cardiac left ventricular ejection fraction outside of protocol requirements
- •6. Known sensitivity to magnesium stearate, croscarmellose sodium or FBS0701
- •7. Platelet count below 150,000/µL and/or absolute neutrophil count less than 1500/mm3 at screening
- •8. Alkaline phosphatase, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) outside of protocol requirements
- •9. Use of any investigational agent within the 30 days prior to the baseline testing
Investigators
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