Trial Condition(s):
Hematologic disease, Hemophilia A
BAY14-2222 Prophylaxis and Joint Function improvement (Adults)
Bayer Identifier:
11859
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 4XW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chapel Hill, United States, 27599 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG, France, 67098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of Joint BleedsTimeframe: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Secondary Outcome
- Number of All BleedsTimeframe: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
- Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert ScoreTimeframe: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
- Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A QuestionnaireTimeframe: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
Additional Information
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