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.
- 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.
- Patients not administered BeneFIX.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | BeneFIX Drug Use Results Survey [All-Case Surveillance] | |||
| Official Title | Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance) | |||
| Brief 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.
| |||
| Detailed Description | Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug. Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs"). The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less." | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug. | |||
| Condition | Hemophilia B | |||
| Intervention | Drug: Nonacog Alfa (Genetical Recombination) Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug. Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs"). The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less." Other Name: BeneFIX | |||
| Study Groups/Cohorts | Nonacog Alfa (Genetical Recombination) Intervention: Drug: Nonacog Alfa (Genetical Recombination) | |||
| 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 | 314 | |||
| Original Estimated Enrollment | 300 | |||
| Actual Study Completion Date | February 27, 2017 | |||
| Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender | Not Provided | |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01154231 | |||
| Other Study ID Numbers | 3090X1-4415 B1821004 B1821009 ( Other Identifier: Alias Study Number ) | |||
| 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 | September 2018 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
