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Clinical Trials/NCT01034904
NCT01034904
Completed
Not Applicable

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).

CSL Behring2 sites in 1 country48 target enrollmentOctober 2009
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ConditionsHemophilia A

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemophilia A
Sponsor
CSL Behring
Enrollment
48
Locations
2
Primary Endpoint
Health Related Quality of Life (HRQoL)
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Health Related Quality of Life (HRQoL)

Time Frame: Every 6 months over 2 to 3 years

Secondary Outcomes

  • Sensitivity of HRQoL measures to significant life events(3 years)

Study Sites (2)

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