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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01034904
First received: December 17, 2009
Last updated: December 8, 2013
Last verified: December 2013

December 17, 2009
December 8, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01034904 on ClinicalTrials.gov Archive Site
Sensitivity of HRQoL measures to significant life events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Patients
Patients who have moderate or severe Hemophilia A, living in Canada and who are using Helixate FS either on-demand or prophylaxis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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
Male
14 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01034904
CE1250_5002_CA
Yes
CSL Behring
CSL Behring
Not Provided
Principal Investigator: Jean St-Louis, MD St. Justine's Hospital
CSL Behring
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP