Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
NCT00484185
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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).
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B | |||
| Official Title | Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B | |||
| Brief 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 | |||
| Detailed Description | The patients who meet the inclusion criteria will be enrolled consecutively. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Hemophilia B (congenital factor IX deficiency or Christmas disease). | |||
| Condition | Hemophilia B | |||
| Intervention | Drug: BeneFIX (coagulation factor IX (recombinant))
BeneFIX will be administered according to physician's discretion. | |||
| Study Groups/Cohorts | 1
Intervention: Drug: BeneFIX (coagulation factor IX (recombinant)) | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 183 | |||
| Original Enrollment | 600 | |||
| Actual Study Completion Date | June 2012 | |||
| Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00484185 | |||
| Other Study ID Numbers | 3090X1-4403 B1821005 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2013 | |||