The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
- Patients with hemophilia A of any severity already receiving or starting treatment
with ReFacto AF.
- Patients with Hemophilia A treated with a product other than Refacto AF.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Pharmacovigilance Of Refacto AF | |||
| Official Title | Pharmacovigilance Evaluation Of Refacto Af (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 Refacto AF in usual health care settings in Germany and Austria. | |||
| 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 A | |||
| Condition | Hemophilia A | |||
| Intervention | Drug: ReFacto AF (Moroctocog alfa) Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively | |||
| Study Groups/Cohorts | 1 Patients treated with Refacto AF Intervention: Drug: ReFacto AF (Moroctocog alfa) | |||
| 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 | 101 | |||
| Original Estimated Enrollment | 180 | |||
| Actual Study Completion Date | October 19, 2016 | |||
| Actual Primary Completion Date | October 19, 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 | NCT00895037 | |||
| Other Study ID Numbers | 3082B2-4420 B1831016 ( 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 2017 | |||
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
