BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00586521
First received: December 21, 2007
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Disease Hemophilia A |
Drug: Kogenate (BAY14-2222) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Number of Joint Bleeds [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ] [ Designated as safety issue: No ]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 [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ] [ Designated as safety issue: No ]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 [ Time Frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) ] [ Designated as safety issue: No ]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 [ Time Frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) ] [ Designated as safety issue: No ]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.
| Enrollment: | 20 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rFVIII-FS (octocog-alfa), (Kogenate FS)
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.
|
Drug: Kogenate (BAY14-2222)
One group two treatment schedules, first on-demand then switch to prophylaxis
|
Eligibility| Ages Eligible for Study: | 30 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586521
Locations
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| France | |
| Strasbourg, France, 67098 | |
| Italy | |
| Firenze, Italy, 50134 | |
| Pavia, Italy, 27100 | |
| Roma, Italy, 00161 | |
| Spain | |
| Sta. Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38009 | |
| Madrid, Spain, 28046 | |
| United Kingdom | |
| Cardiff, South Glamorgan, United Kingdom, CF14 4XW | |
| Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00586521 History of Changes |
| Other Study ID Numbers: | 11859, 2005-002757-45 |
| Study First Received: | December 21, 2007 |
| Results First Received: | April 3, 2009 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Coagulation Disorders |
Additional relevant MeSH terms:
|
Hematologic Diseases Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013