Study Evaluating Refacto For Pharmacovigilance

NCT ID: NCT00195442

Last Updated: 2011-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients with Hemophilia A

Moroctocog alfa

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ReFacto

Eligibility Criteria

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Inclusion Criteria

* Proven diagnosis of Hemophilia A

Exclusion Criteria

* Contraindications according to Summary of Product Characteristics
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Vienna, Vienna, Austria

Site Status

Pfizer Investigational Site

Berlin, Germany, Germany

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Pfizer Investigational Site

Wiesbaden, Germany, Germany

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Pfizer Investigational Site

Frankfurt am Main, Hesse, Germany

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Pfizer Investigational Site

Giessen, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Pfizer Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

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Bonn, North Rhine-Westphalia, Germany

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Halle, Saxony-Anhalt, Germany

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Pfizer Investigational Site

Stadtroda, Thuringia, Germany

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Berlin, , Germany

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Bermen, , Germany

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Erlangen, , Germany

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Pfizer Investigational Site

Frankfurt A. M., , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Homburg, , Germany

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Klipphausen, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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München, , Germany

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Pfizer Investigational Site

München, , Germany

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Pfizer Investigational Site

Münster, , Germany

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Pfizer Investigational Site

Potsdam, , Germany

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Pfizer Investigational Site

Schwerin, , Germany

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Pfizer Investigational Site

Ulm, , Germany

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Countries

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Austria Germany

Related Links

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Other Identifiers

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3082A-100690

Identifier Type: -

Identifier Source: org_study_id

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