- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085344
Canadian Hemophilia Prophylaxis Study (CHPS)
Moderate Term Musculoskeletal Outcomes With Escalating Dose Prophylaxis: the Canadian Hemophilia Prophylaxis Study Follow-up Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Factor VIII
escalating dose Factor VIII
|
escalating dose prophylaxis
Other Names:
escalating dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Developed Target Joint Bleeding
Time Frame: 6 months
|
The number of participants who developed target joint bleeding during the study, which was defined as 3 bleeds into any 1 joint within a period of 3 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Annualized Bleeding Rate
Time Frame: 6 months
|
Number of index hemarthorses (bleeds into ankles, elbows or knees) per patient per year
|
6 months
|
Annualized Factor Use
Time Frame: 12 months
|
annual factor usage per subject
|
12 months
|
Number of Patients Who Developed an Inhibitor to FVIII
Time Frame: 6 months
|
The number of patients who developed an inhibitor for FVIII, defined as >= 0.5 Bethesda Units
|
6 months
|
Physical Disability as Measured by the CHAQ
Time Frame: through study completion, a median of 10 years
|
complete the Child Health Assessment Questionnaire (CHAQ) at each 6 month visit. The CHAQ is a validated tool to measure a disability index, with a possible score range of 0-3, where 0 represents no disability and 3 represents maximal disability. The CHAQ is known to have a strong ceiling effect. The CHAQ was collected at each study visit (i.e. every 6 months for the duration each patient was on study). The reported score represents the median end of study score. |
through study completion, a median of 10 years
|
Joint Damage as Determined by the Physiotherapy Score
Time Frame: through study completion, a median of 10 years
|
Complete the modified Colarado Physiotherapy Assessment every 6 months at each visit with a score range 0-30 for ankles and knees and 0-26 for elbows), measured at all study visits, which we modified by not assessing crepitus or the ankle joint circumference measurement.
For each scale, 0 represents no joint damage, with 26/30 representing maximum possible joint damage.
The reported score represents the median end of study score
|
through study completion, a median of 10 years
|
Complications Arising From Indwelling Venous Catheter
Time Frame: 6 months
|
collect information on any complications relating to indwelling venous catheters that some subject use.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian M Feldman, MD, The Hospital for Sick Children
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0019970022
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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