Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00782470

Purpose

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Condition	Intervention	Phase
Hematologic Disease Blood Coagulation Disorders	Behavioral: Kogenate (BAY 14-2222)	Phase IV

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Hemophilia

Drug Information available for: Factor VIII Octocog alfa

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	A Prospective, Non-Interventional, Multi-Center, Open-Label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and on-Demand Treatment Regimen

Further study details as provided by Bayer:

Primary Outcome Measures:

To evaluate the frequency of all bleeds (spontaneous and trauma) during the study [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the change from baseline in HRQoL (health-related quality of life) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy [ Time Frame: End of Study ] [ Designated as safety issue: No ]
To evaluate the change from baseline in the Gilbert score [ Time Frame: End of Study ] [ Designated as safety issue: No ]
To evaluate the number of target joint development [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1	Behavioral: Kogenate (BAY 14-2222) Subjects electing to stay on the prophylactic treatment (prospective)
Arm 2	Behavioral: Kogenate (BAY 14-2222) Subjects electing to switch to on-demand treatment (prospective)
Arm 3	Behavioral: Kogenate (BAY 14-2222) Subjects remaining on-demand treatment (retrospective)

Eligibility

Ages Eligible for Study:	14 Years to 29 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 - Retrospective On-demand Group

Criteria

Inclusion Criteria:

Severe hemophilia A (<2%)
For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
Current treatment with rFVIII

Exclusion Criteria:

Other known hematological / bleeding disorders other than hemophilia A
Participating on another study that may have an impact on bleeding or the objectives of this study
Known alcohol and drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782470

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

United States, California
	Not yet recruiting
Duarte, California, United States, 91010
United States, Colorado
	Recruiting
Denver, Colorado, United States, 80262
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States, 89109
United States, Texas
	Not yet recruiting
Houston, Texas, United States, 77030
	Recruiting
Fort Worth, Texas, United States, 76104-2796
Canada
	Not yet recruiting
ask Contact, Canada
Germany
	Not yet recruiting
ask Contact, Germany
United Kingdom
	Not yet recruiting
ask Contact, United Kingdom
United Kingdom, Greater London
	Not yet recruiting
London, Greater London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	12749
Study First Received:	October 29, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00782470
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

Vascular Diseases
Hemorrhage
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulants
Coagulation Protein Disorders
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009