Active Drug Surveillance Program of Ferriprox Use

ApoPharma

Status: Completed

Conditions: Transfusional Iron Overload

Study type: Observational

Funder types: Industry

Identifiers

NCT01838291

LA35-PM

Details and patient eligibility

About

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

Full description

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

Enrollment: 294 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Patients who started Ferriprox therapy less than one month or are to initiate Ferriprox therapy at the time of enrolment into the program.

Main Exclusion Criteria:

• Patients treated with Ferriprox for more than one month prior to enrolment.

Trial design

294 participants in 1 patient group

Patients on Ferriprox therapy <1 month