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OpenTrials
Completed

NCT Number: NCT00654589

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

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.

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Key information

Conditions

Iron Overload Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Leipzig, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Deferasirox

Drug

Other names: ICL670

Primary outcomes

  1. To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox

    Time frame: 52 weeks

Secondary outcomes

  1. To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2008
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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