check_circleStudy Completed

Hematologic Disease, Blood Coagulation Disorders

Bayer Identifier:

12749

ClinicalTrials.gov Identifier:

NCT00782470

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

Trial purpose

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Key Participants Requirements

Sex

Male

Age

14 - 29 Years


  • - Severe hemophilia A (<2%)
    - For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
    - For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
    - For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
    - Current treatment with rFVIII
  • - Other known hematological / bleeding disorders other than hemophilia A
    - Participating on another study that may have an impact on bleeding or the objectives of this study
    - Known alcohol and drug abuse

Trial summary

Enrollment Goal
38
Trial Dates
December 2007 - November 2010
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many Locations, Germany
Completed
Hemophilia Treatment Center of Las VegasLas Vegas, 89109, United States
Completed
Gulf States Hemophilia & Thrombophilia CenterHouston, 77030, United States
Terminated
Capitol Comprehensive Cancer CenterJefferson City, 65109, United States
Completed
City of Hope National Medical CenterDuarte, 91010, United States
Completed
Comprehensive Bleeding Disorder CenterPeoria, 61614, United States
Terminated
Many Locations, Canada
Completed
University of Colorado Health Sciences CenterDenver, 80262, United States
Completed
Cook Children's Medical CenterFort Worth, 76104, United States
Terminated
Many Locations, United Kingdom

Primary Outcome

  • To evaluate the frequency of all bleeds (spontaneous and trauma) during the study
    date_rangeTime Frame:
    End of Study
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • To evaluate the change from baseline in HRQoL (health-related quality of life)
    date_rangeTime Frame:
    End of Study
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy
    date_rangeTime Frame:
    End of Study
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the change from baseline in the Gilbert score
    date_rangeTime Frame:
    End of Study
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the number of target joint development
    date_rangeTime Frame:
    End of Study
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Prospective, non-interventional, multi-center, open-label study to evaluate the reasons and consequences of bleeding in late teens and early adulthood subjects with severe hemophilia A receiving prophylaxis and on-demand treatment regimen
Trial Type
Observational
Intervention Type
Behavioral
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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