WHIPPANY, N.J., Dec. 10, 2015 /PRNewswire/ -- New Phase III data from Bayer's LEOPOLD Kids clinical trial investigating the safety and efficacy of BAY 81-8973 in previously treated children were published online today in Haemophilia, the official peer-reviewed journal of the World Federation of Hemophilia.
BAY 81-8973 is an investigational agent and is not approved by the U.S. Food and Drug Administration, the European Medicines Agency (EMA) or other health authorities. Bayer has submitted marketing applications for BAY 81-8973 in several countries, including the U.S.
LEOPOLD Kids is a two-part, open-label, non-randomized phase III study. Part A was designed to evaluate the efficacy and safety of BAY 81-8973 for prophylaxis, treatment of bleeds, and surgical management in previously treated children 12 years of age and younger, using regimens of two times or three times per week or every other day. Part B of the study, which involves previously untreated patients (PUPs), is ongoing.
Hematology at Bayer includes numerous compounds in various stages of development for hemophilia, sickle cell anemia, thalassemia and other blood and bleeding disorders. Together, these compounds reflect the company's commitment to research and development, prioritizing specific targets for intervention with the potential to improve the way that rare blood and bleeding disorders are treated.
The LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) Clinical Development Program consists of three multinational clinical trials designed to evaluate the pharmacokinetics, efficacy, and safety of BAY 81-8973 in subjects with severe hemophilia A (<1% FVIII:C). In addition to LEOPOLD Kids, the program includes the LEOPOLD I and LEOPOLD II studies.
LEOPOLD I is an open-label, randomized study. Part A studied the pharmacokinetics of BAY 81-8973. Part B evaluated the safety, tolerability and efficacy of prophylaxis with BAY 81-8973. Part C evaluated hemostatic outcome during major surgery. Included were male patients (ages 12-65 years) with severe hemophilia A (<1% FVIII:C). The primary endpoint of Part B was annualized number of all bleeds over 12 months.
LEOPOLD II is a randomized, cross-over, open-label trial also in male subjects aged 12 to 65 years. In this Phase II/III study, 80 subjects were randomized to receive BAY 81-8973 either as a low-dose prophylaxis regimen (20-30 IU/kg; n=28) twice-per-week, high-dose prophylaxis (30-40 IU/kg; n=31) three-times-per-week, or on-demand (n=21). The primary objective was to demonstrate the superiority of prophylaxis versus on-demand therapy, with the primary endpoint being bleeding frequency at 12 months.
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SOURCE Bayer Corporation