check_circleStudy Completed

Hematologic Disease, Hemophilia A

Bayer Identifier:

11859

ClinicalTrials.gov Identifier:

NCT00586521

EudraCT Number:

2005-002757-45

EU CT Number:

Not Available
BAY14-2222 Prophylaxis and Joint Function improvement (Adults)

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.

Key Participants Requirements

Sex

Male

Age

30 - 45 Years
  • - 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
  • - 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
20
Trial Dates
February 2006 - March 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sheffield, S10 2JF, United Kingdom
Completed
Aurora, 80045, United States
Completed
Houston, 77030, United States
Withdrawn
Madrid, 28046, Spain
Completed
Cardiff, CF14 4XW, United Kingdom
Completed
Chapel Hill, 27599, United States
Completed
STRASBOURG, 67098, France
Completed
Roma, 00161, Italy
Completed
Firenze, 50134, Italy
Completed
Pavia, 27100, Italy
Withdrawn
Sta. Cruz de Tenerife, 38009, Spain

Primary Outcome

  • Number of Joint Bleeds
    date_rangeTime Frame:
    Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
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    Safety Issue:
    No

Secondary Outcome

  • Number of All Bleeds
    date_rangeTime Frame:
    Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
    enhanced_encryption
    Safety Issue:
    No
  • Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score
    date_rangeTime Frame:
    Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
    enhanced_encryption
    Safety Issue:
    No
  • Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire
    date_rangeTime Frame:
    Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
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    Safety Issue:
    Yes

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

Additional Information

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