check_circleStudy Completed
Hemophilia A
Bayer Identifier:
17285
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Patient functioning and well-being, economic, and clinical impact of hemophilia A and its treatment
Trial purpose
The purpose of the study is to improve the understanding of key patient reported outcomes such as quality of life as well as clinical outcomes in hemophilia A, in a global real world setting.
Key Participants Requirements
Sex
MaleAge
16 - N/ATrial summary
Enrollment Goal
272Trial Dates
December 2015 - March 2018Phase
Phase 4Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, United Kingdom | |
Withdrawn | Many Locations, Germany | |
Completed | Many Locations, Japan | |
Withdrawn | Many Locations, Italy | |
Withdrawn | Many Locations, Canada | |
Withdrawn | Many Locations, Netherlands | |
Withdrawn | Many Locations, China | |
Completed | Detroit, United States | |
Completed | Many Locations, Spain | |
Withdrawn | Many Locations, Mexico | |
Completed | Columbus, United States | |
Completed | New Orleans, United States | |
Completed | Aurora, United States | |
Completed | Phoenix, United States | |
Completed | Washington, United States | |
Completed | Minneapolis, United States | |
Withdrawn | Palo Alto, United States | |
Withdrawn | Orange, United States | |
Withdrawn | Many Locations, Taiwan |
Primary Outcome
- Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).date_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of function as measured by Hemophilia Activities List (HAL), Daily Activities including Work Productivity and Activity Impairment Scale (WPAI).date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of Quality of Life as measured by EuroQol-5 Dimension questionnaire 5 Level (EQ5D), Short Form Health Survey (SF-12), Hemophilia Quality of Life Measure for Adults (HAEMO-QoL-A)date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of Quality of Life as measured by EuroQol-5 Dimension questionnaire 5 Level (EQ5D), Short Form Health Survey (SF-12), Hemophilia Quality of Life Measure for Adults (HAEMO-QoL-A)Resources: Hospital and Healthcare professional visitsdate_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of Quality of Life as measured by EuroQol-5 Dimension questionnaire 5 Level (EQ5D), Short Form Health Survey (SF-12), Hemophilia Quality of Life Measure for Adults (HAEMO-QoL-A)date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of Quality of Life as measured by EuroQol-5 Dimension questionnaire 5 Level (EQ5D), Short Form Health Survey (SF-12), Hemophilia Quality of Life Measure for Adults (HAEMO-QoL-A)date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of Quality of Life as measured by EuroQol-5 Dimension questionnaire 5 Level (EQ5D), Short Form Health Survey (SF-12), Hemophilia Quality of Life Measure for Adults (HAEMO-QoL-A)date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of treatment patterns as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT) and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of treatment patterns as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT) and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of treatment patterns as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT) and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of treatment patterns as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT) and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported Outcome: Change of treatment patterns as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT) and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of adherence as measured by and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of adherence as measured by and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of adherence as measured by and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of adherence as measured by and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of adherence as measured by and Validated Hemophilia Regimen Treatment Adherence Scale (Veritas Pro/PRN)date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of satisfaction as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT)date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of satisfaction as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT)date_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of satisfaction as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT)date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of satisfaction as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT)date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of satisfaction as measured by Hemophilia Treatment Satisfaction Questionnaire (Hemo-SAT)date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of pain as measured by Brief Pain Inventory (Short Form) (BPI-SF)date_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of pain as measured by Brief Pain Inventory (BPI-SF)date_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of pain as measured by Brief Pain Inventory (BPI-SF)date_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of pain as measured by Brief Pain Inventory (BPI-SF)date_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of pain as measured by Brief Pain Inventory (BPI-SF)date_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of number of resource utilization as evaluated from the patient perspectivedate_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of number of resource utilization as evaluated from the patient perspectivedate_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of number of resource utilization as evaluated from the patient perspectivedate_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of number of resource utilization as evaluated from the patient perspectivedate_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of number of resource utilization as evaluated from the patient perspectivedate_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of well-being as measured by Psychological General Well Being Schedule (PGWBI) as well as Smoking and drinking behavior and recreational drug usedate_rangeTime Frame:Baseline and at 12 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of well-being as measured by Psychological General Well Being Schedule (PGWBI) as well as Smoking and drinking behavior and recreational drug usedate_rangeTime Frame:Baseline and at 24 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of well-being as measured by Psychological General Well Being Schedule (PGWBI) as well as Smoking and drinking behavior and recreational drug usedate_rangeTime Frame:Baseline and at 36 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of well-being as measured by Psychological General Well Being Schedule (PGWBI) as well as Smoking and drinking behavior and recreational drug usedate_rangeTime Frame:Baseline and at 48 monthsenhanced_encryptionNoSafety Issue:
- Patient Reported outcome: Change of well-being as measured by Psychological General Well Being Schedule (PGWBI) as well as Smoking and drinking behavior and recreational drug usedate_rangeTime Frame:Baseline and at 60 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Clinical Outcome: Change of Hemophilia A statusHemophilia A status as defined by: - Last measured FVIII level - History of intracranial hemorrhage and age of occurrence - Number of Bleeding episodes/events in the last year - Location of bleed - Confirmed microbleeds on past imaging - PK assessment (if available): Name of FVIII product for most recent PK evaluation - Dose of Factor VIII product administered for most recent PK evaluation - Measured Factor VIII level - Factor VIII half-life and time point of measurement -- Central Venous Access Device (CVAD) or AV (arterial-venous) fistulaedate_rangeTime Frame:Baseline and every 12 months up to 60 monthsenhanced_encryptionNoSafety Issue:
- Clinical Outcome: Change of Joint StatusJoint Status as defined by: - Hemophilia Joint Health Score/ Pettersson Additive Scale - Range of motion - Imaging (where available) - Target joints and past surgical proceduresdate_rangeTime Frame:Baseline and every 12 months up to 60 monthsenhanced_encryptionNoSafety Issue:
- Clinical Outcome: Baseline disease characteristicsBaseline disease characteristics and disease course as defined by: - Date of diagnosis of Hemophilia A - Age at first treatment with factor replacement therapy (child/adult) - Type of factor VIII gene mutation (if available) - Factor VIII level at initial diagnosis (if available) - History of inhibitor and assay used for detection - Date of determination of peak level of inhibitordate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Clinical Outcome: Change of treatment patterns including Hemophilia treatments via patient chartTreatment patterns as measured by: - Treatment choice and dose (Factor VIII use and type) - Treatment Regimen - Immune tolerance therapy - Products for inhibitors - Blood bank products - Non plasma and topical productsdate_rangeTime Frame:Baseline and every 12 months up to 60 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A