Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01546415
First received: November 10, 2011
Last updated: May 27, 2014
Last verified: May 2014

November 10, 2011
May 27, 2014
October 2011
November 2013   (final data collection date for primary outcome measure)
Change in serum ferritin from baseline to 52 weeks with desferasirox treatment in Chinese patients with AA presenting with transfusional hemosiderosis and pre-existing serum ferritin levels of ≥ 1000 ng/mL. [ Time Frame: Every 4 Weeks for 52 weeks of treatment ] [ Designated as safety issue: No ]
Difference in serum ferritin from baseline vs. 52 weeks of treatment.
Same as current
Complete list of historical versions of study NCT01546415 on ClinicalTrials.gov Archive Site
  • Correlation between serum ferritin (SF) and transferrin saturation (TFS) [ Time Frame: Every 4 Weeks for 52 weeks of treatment ] [ Designated as safety issue: No ]
    Study will compare SF with TFS level to find degree of relationship measured by correlation.
  • Number of dispensed, used, partially used or unused packages of study medication to assess drug usage compliance [ Time Frame: Every 4 Weeks for 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Correlation between dose adjustment (increase or decrease) regimens and transfusional burden [ Time Frame: Every 3 months for 52 Weeks of treatment ] [ Designated as safety issue: No ]
    Evaluation of the relationship between dose adjustment regimens (as dictated by both efficacy and safety parameters) and transfusional burden will be undertaken.
  • Number of patients with adverse events, serious adverse events and death [ Time Frame: Every 4 weeks for 52 Weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia
A Single Arm, Multicenter, Open Label Study of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia

The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iron Overload
Drug: Desferasirox
Initial Dose: 20 mg/kg/d. Dose modification according to protocol.
Experimental: Desferasirox
Intervention: Drug: Desferasirox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients presenting with transfusion-related IOL as shown by a SF level of ≥ 1000 ng/mL at start of study
  • History of transfusion >20 international units or 100 mL/kg of red blood cells
  • Underlying transfusion-dependent illness:

    • AA: Clinically diagnosed AA with bone marrow confirmation of the diagnosis
  • Age ≥ 18 years, male or female
  • Written informed consent obtained from patient prior to any screening procedures.

Exclusion Criteria:

  • Patients with serum creatinine > ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥ 1.0 mg/mg in a non-first void urine sample at baseline. If serum creatinine is found to be > ULN or UPCR is found to be ≥ 1 mg/mg the test can be repeated after 1 month.
  • Creatinine Clearance <40 ml/min
  • Patients with other than AA transfusion-dependent underlying illnesses
  • Patients with a previous history of clinically relevant ocular and/or auditory toxicity related to iron chelation
  • Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
  • history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding
  • history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
  • history of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  • history or presence of impaired renal function as indicated by creatinine or blood urea nitrogen (BUN) values equal or above ULN
  • history of urinary obstruction or difficulty in voiding

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01546415
CICL670ACN01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

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