BAY14-2222 Prophylaxis and Joint Function Improvement (Adults) - Full Text View

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 (BAY 14-2222)	Phase IV

Genetics Home Reference related topics:

hemophilia

MedlinePlus related topics:

Hemophilia

ChemIDplus related topics:

Factor VIII Octocog alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Bayer:

Primary Outcome Measures:

Evaluate the effect of prophylactic treatment on the number of joint bleeds in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. [ Time Frame: Feb 2006 to March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate 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. [ Time Frame: Feb 2006 to March 2008 ] [ Designated as safety issue: No ]
Health-economic data will also be assessed. [ Time Frame: Feb 2006 to March 2008 ] [ Designated as safety issue: No ]

Enrollment:	50
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
Arm 1: Experimental	Drug: Kogenate (BAY 14-2222) 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, 27599-7065

United States, Texas

	Houston, Texas, United States, 77030

France

	STRASBOURG, France, 67091

Italy

	Roma, Italy, 00155

	Firenze, Italy, 50139

	Pavia, Italy, 27100

Spain

	Madrid, Spain, 28046

Spain, Canarias

	Santa Cruz de Tenerife, Canarias, Spain, 38010

United Kingdom, South Glamorgan

	Cardiff, South Glamorgan, United Kingdom, CF14 4XW

United Kingdom, South Yorkshire

	Sheffield, South Yorkshire, United Kingdom, S10 2JF

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer Healthcare Pharmaceutical Inc. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	11859, 2005002757-45
First Received:	December 21, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00586521
Health Authority:	United States: Institutional Review Board

Keywords provided by Bayer:

Coagulation Disorders

Study placed in the following topic categories:

Hemorrhagic Disorders

Genetic Diseases, Inborn

Hematologic Diseases

Blood Coagulation Disorders

Hemophilia A

Hemorrhage

Hemostatic Disorders

Factor VIII

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited

Coagulation Protein Disorders

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00586521