Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: April 2, 2008
Last updated: July 25, 2013
Last verified: July 2013
The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present
Primary Outcome Measures:
- To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2012 (Final data collection date for primary outcome measure)
Other Name: ICL670
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Transfusional iron overload three to six months after HCT with no evidence of active inflammation
- History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
- Patients of either gender and age ≥ 18 years.
- Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
- Non-transfusion related iron overload
- Active malignancy
- Known active viral hepatitis or known HIV positiveness
- Mean levels of alanine aminotransferase (ALT) > 5x ULN
- Treatment with any iron chelator after transplantation
- Uncontrolled systemic hypertension
- Serum creatinine > 1.5 ULN and/or serum creatinine clearance < 60 ml/min
- History of nephrotic syndrome.
- Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
- Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
- Pregnant or breast feeding patients.
Other protocol-defined inclusion/exclusion criteria may apply
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654589
|Novartis Investigative Site
|Leipzig, Germany |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 2, 2008
||July 25, 2013
||Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Keywords provided by Novartis:
Hematopoietic stem cell transplantation
allogeneic hematopoietic stem cell transplantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Iron Metabolism Disorders
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action