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Trial record 1 of 1 for:    NCT00714415
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Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

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ClinicalTrials.gov Identifier: NCT00714415
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 24, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 8, 2008
First Posted Date July 14, 2008
Results First Submitted Date September 11, 2017
Results First Posted Date September 24, 2018
Last Update Posted Date October 25, 2018
Actual Study Start Date January 2008
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2018)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    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 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
  • Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    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. Relatedness to BeneFIX was assessed by the investigator.
  • Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
  • Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.
  • Investigator Assessment of Treatment Tolerability of Participants [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
  • Participant Assessment of Treatment Tolerability [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
Original Primary Outcome Measures
 (submitted: July 11, 2008)
Reporting of Adverse Events [ Time Frame: Ongoing ]
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2018)
  • Mean Total Number of Bleeding Episodes in Participants [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    Participants documented all bleeding episodes in a diary during the study.
  • Mean Total Number of Bleeding Episodes Per Year in Participants [ Time Frame: Baseline until last visit (up to 8.7 years) ]
    Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by 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 Number of Days Missed From School or Work [ Time Frame: Baseline, up to 8.7 years ]
    Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was 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.
  • Investigator Assessment of Treatment Efficacy of Participants [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
  • Investigator Assessment of Treatment Handling of Participants [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
  • Assessment of Treatment Efficacy by the Participants [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
  • Assessment of Treatment Handling by the Participants [ Time Frame: End of study visit (any time up to 8.7 years) ]
    Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
  • Investigator Assessment of Treatment Satisfaction of Participants [ Time Frame: Baseline up to 8.7 years ]
    Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
Official Title Pharmacovigilance Evaluation Of Benefix (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 BeneFix® in usual health care settings in Germany.
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 B
Condition Hemophilia B
Intervention Drug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Study Groups/Cohorts A
Patients with Hemophilia B
Intervention: Drug: BeneFIX
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: September 28, 2018)
80
Original Estimated Enrollment
 (submitted: July 11, 2008)
100
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

  • Patients with hemophilia B treated with a product other than BeneFIX®.
  • Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
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 NCT00714415
Other Study ID Numbers 3090A1-4406
B1821011 ( 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 2018