BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

Stopped early · Phase 2

Conditions studied: Hemophilia A

In brief

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Key facts

Study ID

NCT00623727

Run by

Bayer

People needed

143

Starts

2008-06-01

Expected to finish

2010-10-01

Last updated by the study team

2013-07-15

Who can join

Age: 12 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males aged 12 to 70 years
• Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
• Subjects with equal or greater than 150 exposure days (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

You may not qualify if…

• 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 polyethyleneglycol (PEG)
• Subjects who require any pre-medication for FVIII injections

Where it is running

• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — East Lansing, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Buffalo, New York, United States
• Study site — Rochester, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — Perth, Western Australia, Australia
• Study site — Vienna, State of Vienna, Austria
• Study site — Orange, California, United States

Full record on ClinicalTrials.gov

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