check_circleStudy Completed

Hemophilia A

Bayer Identifier:

17819

ClinicalTrials.gov Identifier:

NCT02284789

EudraCT Number:

Not Available

EU CT Number:

Not Available
Colorado Adult Joint Assessment Scale (CAJAS) validation

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.

Key Participants Requirements

Sex

Male

Age

18 - 50 Years
  • - 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
  • - 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
February 2015 - October 2015
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Aurora, 80045, United States
Completed
Orange, 92868, United States
Completed
Indianapolis, 46260, United States
Completed
Portland, 97239, United States

Primary Outcome

  • Colorado Adult Joint Assessment Score (CAJAS)
    date_rangeTime Frame:
    Up to 25 days
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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