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Canadian Hemophilia Prophylaxis Study (CHPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085344
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children

Brief Summary:
Primary prophylaxis given less frequently initially, with the infusion frequency increased if needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with fewer complications than standard prophylaxis while reducing disability to a greater degree than intermittent therapy.

Condition or disease Intervention/treatment Phase
Severe Hemophilia A Biological: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS) Phase 4

Detailed Description:
There are 2 specific study objectives. The first is to estimate the incidence of target joint bleeding in patients with severe hemophilia A treated (for primary prophylaxis) with Escalating Dose Prophylactic factor replacement. The second objective is to obtain accurate estimates of the direct and indirect costs associated with this protocol for use in a cost-effectiveness model (comparing Escalating Dose with standard prophylaxis and with intermittent therapy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Moderate Term Musculoskeletal Outcomes With Escalating Dose Prophylaxis: the Canadian Hemophilia Prophylaxis Study Follow-up Study
Study Start Date : July 1997
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Factor VIII
escalating dose Factor VIII
Biological: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)
escalating dose prophylaxis
Other Name: Recombinant Factor VIII (antihemophilic agent)

Biological: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)
escalating dose
Other Name: recombinant factor VIII (antihemophilic agent)

Primary Outcome Measures :
  1. the frequency of development of target joint bleeding [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. #of bleeding episodes [ Time Frame: 6 months ]
  2. #of factor infusions [ Time Frame: 6 months ]
    number of infusions and reason for infusion to access cost of treatment

  3. circulating inhibitor [ Time Frame: 6 months ]
    check for presence of inhitibors

  4. physical disability as measured by the CHAQ [ Time Frame: 6 nibths ]
    complete the Child Health Assessment Questionaire at each 6 month visit

  5. joint damage as determined by the physiotherapy score [ Time Frame: 6 months ]
    Complete the modified Colarado Physiotherapy Assessment at each visit

  6. complications arising from indwelling venous catheter [ Time Frame: 6 months ]
    collect information on any complications relating to indwelling venous catheters that some subject use.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 30 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe hemophilia A (factor level less than 2%).
  • Age greater than 1 year and less than or equal to 2.5 years.
  • Normal joints using the World Federation of Hemophilia orthopedic scale.
  • Normal radiographs of joints in which bleeding has occurred using the World Federation of Hemophilia radiographic scale.
  • Platelet count of > 150,000.
  • Informed consent to participate.

Exclusion Criteria:

  • Three or more clinically determined bleeds into any single elbow, knee or ankle.
  • Presence or past history of a circulating inhibitor (level ≥ 0.5 Bethesda Units).
  • Family judged to be non-compliant by the local hemophilia clinic director.
  • Competing risk (symptomatic HIV infection, juvenile rheumatoid arthritis, metabolic bone disease, or other diseases known to cause or mimic arthritis.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085344

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Brian M Feldman, MD The Hospital for Sick Children

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children Identifier: NCT01085344     History of Changes
Other Study ID Numbers: 0019970022
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Brian Feldman, The Hospital for Sick Children:
hemophilia, prophylaxis, cost effectiveness
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII