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Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782470
First Posted: October 31, 2008
Last Update Posted: November 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
October 29, 2008
October 31, 2008
November 3, 2014
December 2007
November 2010   (Final data collection date for primary outcome measure)
To evaluate the frequency of all bleeds (spontaneous and trauma) during the study [ Time Frame: End of Study ]
Same as current
Complete list of historical versions of study NCT00782470 on ClinicalTrials.gov Archive Site
  • To evaluate the change from baseline in HRQoL (health-related quality of life) [ Time Frame: End of Study ]
  • To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy [ Time Frame: End of Study ]
  • To evaluate the change from baseline in the Gilbert score [ Time Frame: End of Study ]
  • To evaluate the number of target joint development [ Time Frame: End of Study ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
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
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.
Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 - Retrospective On-demand Group
  • Hematologic Disease
  • Blood Coagulation Disorders
  • Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
    Subjects electing to stay on the prophylactic treatment (prospective)
  • Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
    Subjects electing to switch to on-demand treatment (prospective)
  • Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
    Subjects remaining on-demand treatment (retrospective)
  • Group 1
    Intervention: Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
  • Group 2
    Intervention: Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
  • Group 3
    Intervention: Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Manco-Johnson MJ, Sanders J, Ewing N, Rodriguez N, Tarantino M, Humphries T; TEEN/TWEN Study Group. Consequences of switching from prophylactic treatment to on-demand treatment in late teens and early adults with severe haemophilia A: the TEEN/TWEN study. Haemophilia. 2013 Sep;19(5):727-35. doi: 10.1111/hae.12177. Epub 2013 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
14 Years to 29 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   United Kingdom,   United States
 
 
NCT00782470
12749
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014