Health Related Quality of Life of Youth and Young Adults With Hemophilia A

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. Identifier: NCT01034904
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
CSL Behring

December 17, 2009
December 18, 2009
December 10, 2013
October 2009
July 2013   (Final data collection date for primary outcome measure)
Health Related Quality of Life (HRQoL) [ Time Frame: Every 6 months over 2 to 3 years ]
Same as current
Complete list of historical versions of study NCT01034904 on Archive Site
Sensitivity of HRQoL measures to significant life events [ Time Frame: 3 years ]
Same as current
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Health Related Quality of Life of Youth and Young Adults With Hemophilia A
A Prospective Non-Interventional Study to Describe Health Related Quality of Life of Youth and Young Adults With Moderate or Severe Hemophilia A Using Recombinant Factor VIII (Helixate FS).
The relevance of the study will be in establishing whether Health Related Quality of Life (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances related to the transition from youth to adulthood. This may support the future use of HRQoL measures as part of routine care in order to identify important changes that are not detectible by other clinical means.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
The study is focused on youth (14.0 to 18.0 years of age) and young adults (18.01 to 29.99 years of age), living in Canada, who have moderate and severe Hemophilia A, and who are using Helixate FS either on-demand or as prophylaxis treatment.
Hemophilia A
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Patients who have moderate or severe Hemophilia A, living in Canada and who are using Helixate FS either on-demand or prophylaxis
St-Louis J, Urajnik DJ, Ménard F, Cloutier S, Klaassen RJ, Ritchie B, Rivard GE, Warner M, Blanchette V, Young NL. Generic and disease-specific quality of life among youth and young men with Hemophilia in Canada. BMC Hematol. 2016 May 5;16:13. doi: 10.1186/s12878-016-0052-x. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate or severe Hemophilia A (factor level ≤5%)
  • Receiving Helixate FS as on-demand treatment or prophylaxis therapy at time of informed consent
  • Patient age 14 to 29 years at the time of recruitment
  • Complete informed consent process and documentation; (Patients under age 18 must assent in addition to consent of legal guardian)
  • Willing/able to follow study protocol, including keeping a bleeding and treatment diary
  • Able to communicate clearly in either English or French - both written and verbal communication is essential.

Exclusion Criteria:

  • Known inhibitor at time of recruitment (> 0,5 Bethesda units) or immune tolerance therapy at time of recruitment
  • HIV positive
  • Symptomatic Hepatitis B or C infection or active treatment for hepatitis B or C
  • Inability to comply with study protocol
  • Hypersensitivity to Helixate FS or to any ingredients in the formulation or component of the container
  • Hypersensitivity to mouse or hamster protein
  • Unsuitable to participate in study for any other reason as assessed by investigator
Sexes Eligible for Study: Male
14 Years to 30 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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CSL Behring
CSL Behring
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Principal Investigator: Jean St-Louis, MD St. Justine's Hospital
CSL Behring
December 2013