Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
NCT00714415
Last updated date
ABOUT THIS STUDY
The purpose of this observational study is to describe the incidence of adverse events among
patients treated with BeneFix® in usual health care settings in Germany.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients with hemophilia B treated with a product other than BeneFIX®.
- Inclusion in the ongoing prospective registry of European hemophilia B patients using
BeneFIX®.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Registry For Patients Treated With BeneFix In Usual Care Setting In Germany | |||
| Official Title | Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria | |||
| Brief Summary | The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany. | |||
| Detailed Description | Non-interventional study: subjects to be selected according to the usual clinical practice of their physician | |||
| 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 | Patients with hemophilia B | |||
| Condition | Hemophilia B | |||
| Intervention | Drug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. | |||
| Study Groups/Cohorts | A
Patients with Hemophilia B Intervention: Drug: BeneFIX | |||
| 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 | 80 | |||
| Original Estimated Enrollment | 100 | |||
| Actual Study Completion Date | October 2016 | |||
| Actual Primary Completion Date | October 2016 (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 | Austria, Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00714415 | |||
| Other Study ID Numbers | 3090A1-4406 B1821011 ( 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 | |||