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NCT01034904 Clinical Trial

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

Hemophilia A Clinical Trial

Official title:
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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01034904
Other study ID # CE1250_5002_CA
Secondary ID
Status Completed
Phase N/A
First received December 17, 2009
Last updated December 8, 2013
Start date October 2009
Est. completion date November 2013

Study information
Verified date December 2013
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Male
Age group 14 Years to 30 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada CHU Sainte-Justine Montreal Quebec
Canada Sick Kids Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
CSL Behring

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health Related Quality of Life (HRQoL) Every 6 months over 2 to 3 years No
Secondary Sensitivity of HRQoL measures to significant life events 3 years No
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