Last updated date
ABOUT THIS STUDY
The purpose of this study is to investigate the effectiveness and safety of treatment with
ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment
will be done.
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
Male
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
- Proven diagnosis of Hemophilia A
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Contraindications according to Summary of Product Characteristics
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Refacto For Pharmacovigilance | |||
| Official Title | Pharmacovigilance Evaluation Of Refacto In Usual Care Settings | |||
| Brief Summary | The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done. | |||
| 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: Moroctocog alfa
Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. Other Name: ReFacto | |||
| Study Groups/Cohorts | A
Patients with Hemophilia A Intervention: Drug: 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 | 288 | |||
| Original Enrollment | 150 | |||
| Actual Study Completion Date | January 2010 | |||
| Actual Primary Completion Date | January 2010 (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 | NCT00195442 | |||
| Other Study ID Numbers | 3082A-100690 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | February 2011 | |||