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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01034904
First received: December 17, 2009
Last updated: August 26, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Hemophilia A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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).

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Health Related Quality of Life (HRQoL) [ Time Frame: Every 6 months over 2 to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity of HRQoL measures to significant life events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients who have moderate or severe Hemophilia A, living in Canada and who are using Helixate FS either on-demand or prophylaxis

  Eligibility

Ages Eligible for Study:   14 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034904

Locations
Canada, Ontario
Sick Kids Hospital
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Jean St-Louis, MD St. Justine's Hospital
  More Information

Additional Information:
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01034904     History of Changes
Other Study ID Numbers: CE1250_5002_CA
Study First Received: December 17, 2009
Last Updated: August 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by CSL Behring:
Quality of Life
HRQoL
Hemophilia A
Helixate FS

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013