NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

BeneFIX Drug Use Results Survey [All-Case Surveillance]

CompletedN/A

Sponsor: Pfizer

Conditions: Hemophilia B

Interventions: Nonacog Alfa (Genetical Recombination)

Countries: Japan

The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch. 1. Occurrence status of adverse events 2. Factors that may influence the safety 3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
* No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.

Exclusion Criteria:

* Patients not administered BeneFIX.

Locations (1)

Shinjuku-ku, Tokyo, Japan