Eligibility criteria
Condition
Hemophilia A
Sex
Male
Age
0 +
Inclusion criteria
Show details
- Proven diagnosis of Hemophilia A
Exclusion criteria
Show details
- Contraindications according to Summary of Product Characteristics
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Study Evaluating Refacto For Pharmacovigilance
NCT00195442
Last updated on October 14, 2019
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.
NCT00195442
Pfizer
Completed
Study Evaluating Refacto For Pharmacovigilance
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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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| 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 | |||
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