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Study Evaluating Pharmacovigilance Of Refacto AF

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ClinicalTrials.gov Identifier: NCT00895037
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 1, 2009
First Posted Date May 7, 2009
Results First Submitted Date September 22, 2017
Results First Posted Date July 17, 2018
Last Update Posted Date July 17, 2018
Actual Study Start Date July 17, 2009
Actual Primary Completion Date October 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2017)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline until last visit (up to 87 months) ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
  • Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline until last visit (up to 87 months) ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.
  • Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay [ Time Frame: Baseline until last visit (up to 87 months) ]
    FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
  • Mean Total Number of Bleeding Episodes in Participants [ Time Frame: Baseline until last visit (up to 87 months) ]
    Participants documented all bleeding episodes in a diary during the study.
Original Primary Outcome Measures
 (submitted: May 5, 2009)
Reporting of adverse events [ Time Frame: 36 months ]
Change History Complete list of historical versions of study NCT00895037 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 22, 2017)
  • Mean Total Number of Bleeding Episodes Per Year in Participants [ Time Frame: Baseline until last visit (up to 87 months) ]
    Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
  • Number of Participants With Change From Baseline Status in Days Missed From School or Work [ Time Frame: Baseline until last visit (up to 87 months) ]
    Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
  • Participant Assessment of Satisfaction With Treatment Handling [ Time Frame: End of study visit (any time up to 87 months) ]
    Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.
  • Investigator Assessment of Treatment Satisfaction of Participants [ Time Frame: End of study visit (any time up to 87 months) ]
    Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.
Original Secondary Outcome Measures
 (submitted: May 5, 2009)
Efficacy in controlling bleeding [ Time Frame: 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Pharmacovigilance Of Refacto AF
Official Title Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
Brief Summary The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
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: ReFacto AF (Moroctocog alfa)
Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively
Study Groups/Cohorts 1
Patients treated with Refacto AF
Intervention: Drug: ReFacto AF (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
 (submitted: August 28, 2017)
101
Original Estimated Enrollment
 (submitted: May 5, 2009)
180
Actual Study Completion Date October 19, 2016
Actual Primary Completion Date October 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.

Exclusion Criteria:

  • Patients with Hemophilia A treated with a product other than Refacto AF.
Sex/Gender
Sexes Eligible for Study: All
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 NCT00895037
Other Study ID Numbers 3082B2-4420
B1831016 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2017