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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia A

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Quality of Life HRQoL Hemophilia A Helixate FS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Patients who have moderate or severe Hemophilia A, living in Canada and who are using Helixate FS either on-demand or prophylaxis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean St-Louis, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sick Kids Hospital

Toronto, Ontario, Canada

Site Status

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

St-Louis J, Urajnik DJ, Menard F, Cloutier S, Klaassen RJ, Ritchie B, Rivard GE, Warner M, Blanchette V, Young NL. Generic and disease-specific quality of life among youth and young men with Hemophilia in Canada. BMC Hematol. 2016 May 5;16:13. doi: 10.1186/s12878-016-0052-x. eCollection 2016.

Reference Type DERIVED

PMID: 27158500 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE1250_5002_CA

Identifier Type: -

Identifier Source: org_study_id