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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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00654589
First received: April 2, 2008
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Iron Overload
 Drug: Deferasirox
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Deferasirox
U.S. FDA Resources

Further study details as provided by Novartis:

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 ]

Enrollment: 75
Study Start Date: February 2008
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deferasirox Drug: Deferasirox
Other Name: ICL670

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Transfusional iron overload three to six months after HCT with no evidence of active inflammation
  2. History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
  3. Patients of either gender and age ≥ 18 years.
  4. 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.

Exclusion criteria:

  1. Non-transfusion related iron overload
  2. Active malignancy
  3. Known active viral hepatitis or known HIV positiveness
  4. Mean levels of alanine aminotransferase (ALT) > 5x ULN
  5. Treatment with any iron chelator after transplantation
  6. Uncontrolled systemic hypertension
  7. Serum creatinine > 1.5 ULN and/or serum creatinine clearance < 60 ml/min
  8. History of nephrotic syndrome.
  9. Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
  10. Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
  11. Pregnant or breast feeding patients.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654589

Locations
Germany
Novartis Investigative Site
Leipzig, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00654589     History of Changes
Other Study ID Numbers: CICL670ADE02
Study First Received: April 2, 2008
Last Updated: March 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:
Hematopoietic stem cell transplantation
HCT
iron overload
chelators
ICL670
deferasirox
serum ferritin
 LIC
transfusional hemosiderosis
blood transfusions
adults
iron chelation
3-6 months
allogeneic hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
 Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013