Canadian Hemophilia Prophylaxis Study (CHPS)
This study is ongoing, but not recruiting participants.
Sponsor:
The Hospital for Sick Children
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01085344
First received: March 1, 2010
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Severe Hemophilia A |
Biological: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Moderate Term Musculoskeletal Outcomes With Escalating Dose Prophylaxis: the Canadian Hemophilia Prophylaxis Study Follow-up Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- the frequency of development of target joint bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- #of bleeding episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- #of factor infusions [ Time Frame: 6 months ] [ Designated as safety issue: No ]number of infusions and reason for infusion to access cost of treatment
- circulating inhibitor [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]check for presence of inhitibors
- physical disability as measured by the CHAQ [ Time Frame: 6 nibths ] [ Designated as safety issue: No ]complete the Child Health Assessment Questionaire at each 6 month visit
- joint damage as determined by the physiotherapy score [ Time Frame: 6 months ] [ Designated as safety issue: No ]Complete the modified Colarado Physiotherapy Assessment at each visit
- complications arising from indwelling venous catheter [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]collect information on any complications relating to indwelling venous catheters that some subject use.
| Enrollment: | 56 |
| Study Start Date: | July 1997 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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).
Eligibility| Ages Eligible for Study: | 12 Months to 30 Months |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085344
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Brian M Feldman, MD | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01085344 History of Changes |
| Other Study ID Numbers: | 0019970022 |
| Study First Received: | March 1, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
hemophilia, prophylaxis, cost effectiveness |
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 16, 2013