Back to resultsBAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Primary Purpose
Hematologic Disease, Hemophilia A
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Kogenate (BAY14-2222)
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Disease focused on measuring Coagulation Disorders
Eligibility Criteria
Inclusion Criteria:
- Severe hemophilia A (< 1% FVIII)
- 30-45 years of age
- Previously treated subject (> 100 Exposure days to any FVIII)
- On-demand therapy with any FVIII
Exclusion Criteria:
- No history of inhibitor
- No planned elective orthopedic surgery during the study duration (13 months)
- No severe concomitant disease
- No history of anaphylactic or other severe reaction to previous FVIII treatment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rFVIII-FS (octocog-alfa), (Kogenate FS)
Arm Description
On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
Outcomes
Primary Outcome Measures
Number of Joint Bleeds
Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6
Secondary Outcome Measures
Number of All Bleeds
Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)
Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score
Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage
Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire
Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00586521
Brief Title
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Official Title
A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.
In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Disease, Hemophilia A
Keywords
Coagulation Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rFVIII-FS (octocog-alfa), (Kogenate FS)
Arm Type
Experimental
Arm Description
On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
Intervention Type
Drug
Intervention Name(s)
Kogenate (BAY14-2222)
Intervention Description
One group two treatment schedules, first on-demand then switch to prophylaxis
Primary Outcome Measure Information:
Title
Number of Joint Bleeds
Description
Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6
Time Frame
Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Secondary Outcome Measure Information:
Title
Number of All Bleeds
Description
Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)
Time Frame
Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Title
Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score
Description
Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage
Time Frame
Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
Title
Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire
Description
Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.
Time Frame
Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe hemophilia A (< 1% FVIII)
30-45 years of age
Previously treated subject (> 100 Exposure days to any FVIII)
On-demand therapy with any FVIII
Exclusion Criteria:
No history of inhibitor
No planned elective orthopedic surgery during the study duration (13 months)
No severe concomitant disease
No history of anaphylactic or other severe reaction to previous FVIII treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Firenze
ZIP/Postal Code
50134
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Sta. Cruz de Tenerife
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38009
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
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