Study Evaluating Refacto For Pharmacovigilance

February 7, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Pharmacovigilance Evaluation Of Refacto In Usual Care Settings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Berlin, Germany, 10249
        • Pfizer Investigational Site
      • Bermen, Germany, 28205
        • Pfizer Investigational Site
      • Erlangen, Germany, 91054
        • Pfizer Investigational Site
      • Frankfurt a. M., Germany, 60594
        • Pfizer Investigational Site
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69123
        • Pfizer Investigational Site
      • Homburg, Germany, 66424
        • Pfizer Investigational Site
      • Klipphausen, Germany, 01665
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Lubeck, Germany, 23538
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
      • Muenchen, Germany, 80337
        • Pfizer Investigational Site
      • Muenster, Germany, D-48143
        • Pfizer Investigational Site
      • Potsdam, Germany, 14467
        • Pfizer Investigational Site
      • Schwerin, Germany, 19049
        • Pfizer Investigational Site
      • Ulm, Germany, 89081
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65191
        • Pfizer Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • Pfizer Investigational Site
      • Giessen, Hessen, Germany, 35385
        • Pfizer Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18055
        • Pfizer Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Pfizer Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
        • Pfizer Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Pfizer Investigational Site
    • Thuringen
      • Stadtroda, Thuringen, Germany, 07646
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with hemophilia A

Description

Inclusion Criteria:

  • Proven diagnosis of Hemophilia A

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Patients with Hemophilia A
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 Names:
  • ReFacto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Bleeding Episodes Per Patient Year
Time Frame: Baseline up to a mean duration of 54 months
Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.
Baseline up to a mean duration of 54 months
Mean Number of Bleeding-related Exposure Days Per Patient Year
Time Frame: Baseline up to a mean duration of 54 months
Exposure days are the number of days of treatment with ReFacto.
Baseline up to a mean duration of 54 months
Mean Number of Exposure Days Per Patient Year
Time Frame: Baseline up to a mean duration of 54 months
Exposure days are the number of days of treatment with ReFacto.
Baseline up to a mean duration of 54 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to a mean duration of 54 months
AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs.
Baseline up to a mean duration of 54 months
Number of Participants With de Novo Inhibitor Formation
Time Frame: Baseline up to a mean duration of 54 months
The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required.
Baseline up to a mean duration of 54 months
Mean Annual ReFacto Consumption Per Patient Year
Time Frame: Baseline up to a mean duration of 54 months
ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles.
Baseline up to a mean duration of 54 months
Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Physicians' Assessment of Efficacy
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Patients' Assessment of Efficacy
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Physicians' Assessment of Tolerance
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the physician to evaluate the participants' tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Patients' Assessment of Tolerance
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Physicians' Assessment of Handling of ReFacto
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the physician to evaluate the participants' handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Patients' Assessment of Handling of ReFacto
Time Frame: Baseline up to a mean duration of 54 months
Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.
Baseline up to a mean duration of 54 months
Number of Participants for Days of Sick Leave Per Month
Time Frame: Baseline up to a mean duration of 54 months
Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification.
Baseline up to a mean duration of 54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 7, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3082A-100690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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