Hemophilia A Clinical Trial
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
| Verified date | October 2014 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | March 2008 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 30 Years to 45 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
United States, France, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Joint Bleeds | Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6 | Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) | No |
| Secondary | 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) | Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) | No |
| Secondary | 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 | Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) | No |
| Secondary | 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. | Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) | No |
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