Hemophilia A
Conditions
Keywords
Hemophilia
Brief summary
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.
Interventions
OTHERColorado Adult Joint Assessment Evaluation
Physical evaluation of 6 joints, ankles, knees and elbows
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colorado Adult Joint Assessment Score (CAJAS) | Up to 25 days |
Countries
United States
Outcome results
None listed