Trial Condition(s):

Hemophilia A

Colorado Adult Joint Assessment Scale (CAJAS) validation (CAJAS)

Bayer Identifier:

17819

ClinicalTrials.gov Identifier:

NCT02284789

EudraCT Number:

Not Available

Study Completed

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
30
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Orange, United States, 92868

Status
Completed
 
Locations

Investigative Site

Indianapolis, United States, 46260

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 

Trial Design