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

Tracking Information

First Received Date ^ICMJE

April 2, 2008

Last Updated Date

March 7, 2012

Start Date ^ICMJE

February 2008

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00654589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Iron Overload

Intervention ^ICMJE

Drug: Deferasirox

Other Name: ICL670

Study Arm (s)

Experimental: deferasirox

Intervention: Drug: Deferasirox

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00654589

Other Study ID Numbers ^ICMJE

CICL670ADE02

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

Information Provided By

Novartis

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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