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Study Evaluating Refacto For Pharmacovigilance

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195442
First received: September 13, 2005
Last updated: February 7, 2011
Last verified: February 2011

September 13, 2005
February 7, 2011
July 1999
January 2010   (final data collection date for primary outcome measure)
  • Mean Number of Bleeding Episodes Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Mean Number of Bleeding-related Exposure Days Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    Exposure days are the number of days of treatment with ReFacto.
  • Mean Number of Exposure Days Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    Exposure days are the number of days of treatment with ReFacto.
Not Provided
Complete list of historical versions of study NCT00195442 on ClinicalTrials.gov Archive Site
  • Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With de Novo Inhibitor Formation [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: Yes ]
    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.
  • Mean Annual ReFacto Consumption Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Physicians' Assessment of Efficacy [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Patients' Assessment of Efficacy [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Physicians' Assessment of Tolerance [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Patients' Assessment of Tolerance [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Physicians' Assessment of Handling of ReFacto [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Patients' Assessment of Handling of ReFacto [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants for Days of Sick Leave Per Month [ Time Frame: Baseline up to a mean duration of 54 months ] [ Designated as safety issue: No ]
    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.
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Not Provided
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Study Evaluating Refacto For Pharmacovigilance
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with hemophilia A

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 Name: ReFacto
A
Patients with Hemophilia A
Intervention: Drug: Moroctocog alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Proven diagnosis of Hemophilia A

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00195442
3082A-100690
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP