Clinical Trial: Active Drug Surveillance Program of Ferriprox Use

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Active Drug Surveillance Program of Ferriprox Use

Brief Summary: Observational, open label, prospective, multi-center, post-marketing drug surveillance program.

Detailed Summary: A post-marketing, drug surveillance program evaluating the use, monitoring, benefits and adverse effects of Ferriprox under clinical conditions in newly treated patients.
Sponsor: ApoPharma

Current Primary Outcome:

• Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients. [ Time Frame: Baseline to 12 Months ]
  Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s).
• Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients. [ Time Frame: Baseline to 12 Months ]
  Evaluation of how Ferriprox is prescribed/received by the patient: as monotherapy, simultaneous with deferoxamine, alternate with deferoxamine, simultaneous with deferasirox, alternate with deferasirox.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice. [ Time Frame: Baseline to 12 Months ]
  Beneficial effects of Ferriprox will be assessed based on the changes in: serum ferritin and cardiac iron concentration as assessed by MRI T2*.
• Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice. [ Time Frame: Baseline to 12 Months ]
  Adverse effects of Ferriprox will be assessed based on: frequency of absolute neutrophil count (ANC) monitoring, occurrence of neutropenia or agranulocytosis and occurrence of other adverse events (AEs) or adverse drug reactions (ADRs).

Original Secondary Outcome: Same as current

Information By: ApoPharma

Dates:
Date Received: April 15, 2013
Date Started: June 2010
Date Completion:
Last Updated: April 19, 2013
Last Verified: April 2013