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Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: BeneFIX (coagulation factor IX (recombinant)) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the incidences of adverse reactions under the routine drug uses. 3) Factors that may affect the safety of the drug 4) Factors that may affect the effectiveness of the drug

Clinical Details

Official title: Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of Participants With Adverse Events (AEs) According to Baseline Characteristics

Number of Participants With Adverse Events (AEs) According to Severity

Number of Participants With Action Taken in Response to Adverse Events (AEs)

Number of Participants With Adverse Events (AEs) According to Seriousness

Number of Participants With Outcome in Response to Adverse Events (AEs)

Number of Participants With Adverse Events (AEs) by Relationship

Number of Participants With Unexpected Adverse Events (AEs)

Secondary outcome:

Mean Annualized Bleeding Rate (ABR)

Number of Responses to On-demand Treatment With Study Medication

Mean Number of Infusion of Study Medication

Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication

Average Infusion Dose of Study Medication

Total Infusion of Study Medication

Percentage of Participants With Efficacy Evaluation

Detailed description: The patients who meet the inclusion criteria will be enrolled consecutively.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients or legally authorized representatives of pediatric patients agree to provide

written informed consent form (data privacy statement).

- Pediatric and adult patients who have been treated with original or reformulated

BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for example, patients switching from pdFIX to BeneFIX). Exclusion Criteria:

- Patients with a known history of hypersensitivity to original or reformulated BeneFIX

or any component of the product.

- Patients with a known history of hypersensitivity to hamster protein.

- Patients participating in an interventional trial of any investigational drug or

device.

Locations and Contacts

Pfizer Investigational Site, Seoul 137-882, Korea, Republic of
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2007
Last updated: May 15, 2013

Page last updated: August 20, 2015

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