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Completed

NCT Number: NCT02284789

Colorado Adult Joint Assessment Scale (CAJAS) Validation

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Orange, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Colorado Adult Joint Assessment Evaluation

Other

Physical evaluation of 6 joints, ankles, knees and elbows

Primary outcomes

  1. Colorado Adult Joint Assessment Score (CAJAS)

    Time frame: Up to 25 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis

Acronym: CAJAS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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