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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00654589
Other study ID # CICL670ADE02
Secondary ID
Status Completed
Phase Phase 4
First received April 2, 2008
Last updated November 16, 2016
Start date February 2008
Est. completion date January 2012

Study information

Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Deferasirox


Locations

Country Name City State
Germany Novartis Investigative Site Leipzig

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jaekel N, Lieder K, Albrecht S, Leismann O, Hubert K, Bug G, Kröger N, Platzbecker U, Stadler M, de Haas K, Altamura S, Muckenthaler MU, Niederwieser D, Al-Ali HK. Efficacy and safety of deferasirox in non-thalassemic patients with elevated ferritin level — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox 52 weeks No
Secondary To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study. 52 weeks No
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