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

December 8, 2013 updated by: CSL Behring

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).

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Sick Kids Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study is focused on youth (14.0 to 18.0 years of age) and young adults (18.01 to 29.99 years of age), living in Canada, who have moderate and severe Hemophilia A, and who are using Helixate FS either on-demand or as prophylaxis treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of HRQoL measures to significant life events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Principal Investigator: Jean St-Louis, MD, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 8, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE1250_5002_CA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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