Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00845871
First received: February 16, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

This single-arm, open-label, multi-center study will enroll 60 patients from approximately 20 centers. All patients who meet study criteria and are currently taking, beginning or resuming treatment with Deferasirox will be allowed. The study will begin with a one month run-in phase, where all patients will be instructed to take Deferasirox according to their physician's current prescribing information.


Condition Intervention Phase
Transfusional Hemosiderosis
Drug: deferasirox:
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label Study of the Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Palatability of Deferasirox as assessed by the Five-Point Facial Hedonic Scale [ Time Frame: at every week over 4 months (6 visits) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability based on adverse events and laboratory variables. [ Time Frame: At every week over 4 months (6 visits) ] [ Designated as safety issue: Yes ]
  • Measure the pharmacokinetics of Deferasirox when administered with food or with different methods of administration [ Time Frame: at every week over 4 months (6 visits) ] [ Designated as safety issue: No ]
  • Change from baseline in serum ferritin. [ Time Frame: week 4, week 8, week 12, week 16 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: March 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deferasirox
Patients will have five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.
Drug: deferasirox:
deferasirox 20mg/kg/day unless on a higher dose at time of study entry. Crushed or dissolved tablets taken once daily with either breakfast,dinner or no meal for 4 months.
Other Names:
  • Exjade
  • Deferasirox

Detailed Description:

Following the run-in phase, patients will enter a three month, assessment phase. During the assessment phase, patients will have five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with thalassemia major, sickle cell disease (SCD), low or intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and transfusional hemosiderosis.
  • Patients who were on, starting, or resuming treatment with Exjade.
  • Patients who were >2 years (i.e., 2 years of age or older).

Exclusion criteria:

  • Serum creatinine above the upper limit of normal (ULN) for age.
  • Alanine aminotransferase (ALT) >2.5 times the ULN.-High risk intermediate-2 or high risk MDS or acute leukemia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845871

  Show 23 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00845871     History of Changes
Other Study ID Numbers: CICL670AUS32, 2011-004217-17
Study First Received: February 16, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Exjade
deferasirox
palatability
tolerability
food
iron overload
Serum Iron overload due to transfusions

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

ClinicalTrials.gov processed this record on July 31, 2014