CompletedNot Applicable

BeneFIX Drug Use Results Survey [All-Case Surveillance]

Japan314 participantsStarted 2009-10-29

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy

Timeframe: 2 years for PTPs, 1 year for PUPs

Number of Administrations Required for Hemostasis for Bleeding Events

Timeframe: 2 years for PTPs, 1 year for PUPs

Trial details

NCT IDNCT01154231

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-08-29

Results submitted2017-02-28

View on ClinicalTrials.gov More Hemophilia B trials