Kogenate Liplong Study - BAY 79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00623727

Purpose

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (Bay 79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Condition	Intervention	Phase
Hemophilia A	Drug: BAY 79-4980 Drug: BAY 14-2222	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY 79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variable will be the percentage of subjects with less than 9 total bleeds per year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Bleeds, [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Treatment of bleeds, [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Consumption of FVIII, [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: BAY 79-4980 35 IU/kg body weight IV 1x/week for 52 weeks
Arm 2: Active Comparator	Drug: BAY 14-2222 25 IU/kg body weight IV 3x/week for 52 weeks

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males aged 12 to 70 years,
Subjects with severe hemophilia A (< 1% FVIII:C)
Subjects with equal or greater than 150 EDs with any FVIII in total
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule.
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records.
Subjects with no measurable inhibitor activity
Subjects with no history of FVIII inhibitor antibody formation.
Written informed consent by subject and parent / legal representative, if < 18 years

Exclusion Criteria:

Subjects who are receiving primary prophylaxis
Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
Subjects with abnormal renal function
Subjects with elevated hepatic transaminases
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or PEG
Subjects who require any pre-medication for FVIII injections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623727

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 73 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12781, EudraCT-Nr. 2007-003718-32
Study First Received:	January 9, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00623727 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Hemophilia A,
FVIII disease,
rFVIII

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on September 03, 2009