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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00484185 |
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:
Condition | Intervention | Phase |
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Hemophilia B |
Drug: BeneFIX (coagulation factor IX (recombinant)) |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Post-Marketing Surveillance (PMS) Study of Safety and Effectiveness in Patients With BeneFIX Treatment |
Estimated Enrollment: | 600 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2014 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1 |
Drug: BeneFIX (coagulation factor IX (recombinant))
BeneFIX will be administered according to "Dosage and Administration" of the approval labeling
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Primary care clinic, secondary and tertiary medical centers
Inclusion Criteria:
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Korea, Republic of | |
Recruiting | |
Multiple Cities, Korea, Republic of |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3090X1-4403 |
Study First Received: | June 7, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00484185 |
Health Authority: | Korea: Food and Drug Administration |
Hemophilia B Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Hemophilia A Genetic Diseases, X-Linked Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |