Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

Completed · Phase 3

Conditions studied: Blood Coagulation Disorders, Hemophilia A

In brief

The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)

Key facts

Study ID

NCT01029340

Run by

Bayer

People needed

74

Starts

2009-12-01

Expected to finish

2013-03-01

Last updated by the study team

2016-11-28

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, aged 12 to 65 years
• Severe hemophilia A defined as < 1% FVIII:C
• >/= 150 days of previous treatment with FVIII in lifetime
• Currently receiving on-demand or any type of prophylaxis treatment regimen with any FVIII product
• No history of or current FVIII inhibitors

You may not qualify if…

• Presence of another bleeding disease that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B)
• Low platelet count, abnormal kidney function, or liver disease
• Received treatment with immune suppressing drugs within the last 3 months prior or requires treatment during the study. (Some drugs for hepatitis C, Human immunodeficiency virus (HIV), and steroids are allowed)
• Receiving or has received other experimental drugs within 3 months prior to study entry
• Allergy to Factor VIII or hamsters or mouse protein

Where it is running

• Study site — Sacramento, California, United States
• Study site — Tampa, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — East Lansing, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Cleveland, Ohio, United States
• Study site — Bahía Blanca, Buenos Aires, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — Vienna, State of Vienna, Austria
• Study site — Graz, Austria
• Study site — Zagreb, Croatia
• Study site — DK-Aarhus N, Denmark
• Study site — Frankfurt am Main, Hesse, Germany
• Study site — Bonn, North Rhine-Westphalia, Germany
• Study site — Mainz, Rhineland-Palatinate, Germany
• Study site — Homburg, Saarland, Germany
• Study site — Magdeburg, Saxony-Anhalt, Germany
• Study site — Hong Kong, Hong Kong
• Study site — Bangalore, India
• Study site — Mumbai, India
• Study site — Pune, India
• Study site — Jakarta, Indonesia
• Study site — Ramat Gan, Israel
• Study site — Catanzaro, Calabria, Italy
• Study site — Orange, California, United States

Full record on ClinicalTrials.gov

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