Trial Condition(s):

Hematologic disease, Hemophilia A

BAY14-2222 Prophylaxis and Joint Function improvement (Adults)

Bayer Identifier:

11859

ClinicalTrials.gov Identifier:

NCT00586521

EudraCT Number:

2005-002757-45

Study Completed

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
20
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Cardiff, United Kingdom, CF14 4XW

Status
Completed
 
Locations

Investigative Site

Chapel Hill, United States, 27599

Status
Completed
 
Locations

Investigative Site

STRASBOURG, France, 67098

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00161

Status
Completed
 
Locations

Investigative Site

Firenze, Italy, 50134

Status
Completed
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 

Trial Design