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ABOUT THIS STUDY
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.
Study Location
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 A
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 A of any severity already receiving or starting treatment with ReFacto AF.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients with Hemophilia A treated with a product other than Refacto AF.
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Advanced Information
| 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 | |||