Trial Condition(s):
Hemophilia A
Colorado Adult Joint Assessment Scale (CAJAS) validation (CAJAS)
Bayer Identifier:
17819
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.
Inclusion Criteria
- Male, 18 to 50 years of age - Diagnosis of moderate to severe hemophilia A (documented <1-2% Factor VIII Concentration [FVIII:C]) - Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study
Exclusion Criteria
- Routine need for wheelchair or routine need for two canes or crutches - Diagnosis of another bleeding disorder such as von Willebrand Disease - Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orange, United States, 92868 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46260 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evidence and Analysis for the Content Validity of a Clinician Reported Outcomes Measure of Hemophilic Joint Arthropathy in Adults with Moderate to Severe Hemophilia A
Trial Type:
Interventional
Intervention Type:
Other
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Colorado Adult Joint Assessment Score (CAJAS)Timeframe: Up to 25 days
Additional Information
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