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

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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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

14 year–30 year

Sex eligibility

Male

Study type

Observational

Primary location

Sick Kids Hospital, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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).

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Dec 18, 2009
Registry last updated: Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed