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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01034904

Enrollment

Registered

2009-12-18

Start date

2009-10-31

Completion date

2013-11-30

Last updated

2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Quality of Life, HRQoL, Hemophilia A, Helixate FS

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

14 Years to 30 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Health Related Quality of Life (HRQoL)	Every 6 months over 2 to 3 years

Secondary

Measure	Time frame
Sensitivity of HRQoL measures to significant life events	3 years

Countries

Canada

Outcome results