Subjects with hemophilia A or B with inhibitors MedDRA version: 14.1 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 14.1 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850
Conditions
Interventions
Product Name: BAY 86-6150
Product Code: BAY 86-6150, modified recombinant human Factor VII
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: BAY 86-6150
Other de
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male subjects - 12 to 62 years-of-age - History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX - 4 or more bleeding episodes in the last 6 months before enrollment. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Clinically relevant coagulation disorder other than congenital hemophilia A or B with inhibitors - History of coronary and/or peripheral atherosclerotic disease - Disseminated intravascular coagulopathy, or stage 2 hypertension - Angina pectoris - Myocardial infarction - Transient ischemic attack - Stroke - Congestive heart failure - Thromboembolic event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: - To identify the recommended dose by conducting a risk-benefit assessment of four different dose levels of BAY 86-6150 based on safety and dose response assessments in acutely bleeding subjects with hemophilia A or B with inhibitors. Part B: - To further investigate the safety and efficacy of the recommended dose of BAY 86-6150 in acutely bleeding subjects with hemophilia A or B with inhibitors.;Secondary Objective: - To assess the potential immunogenicity of BAY 86-6150 in subjects with hemophilia A or B with inhibitors. - To evaluate the comparative PK/PD (pharmacokinetics/pharmacodynamics) parameters to one fixed dose of eptacog alfa (activated) in a subset of the above cohorts at the same four dose levels of BAY 86-6150.;Primary end point(s): 1. Successful treatments of bleeding episodes. (A bleed was defined as successfully treated, if no administration of rescue medication was required.) 2. Proportion of successful treatments of bleeding episodes on subject level. (Proportion of successful treatments of bleeding episodes was calculated as number of bleeding episodes treated successfully - without rescue medication - divided by the total number of bleeding episodes on a dose level.);Timepoint(s) of evaluation of this end point: 1. 10 hours after each bleed 2. 10 hours after each bleed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to stop the bleed. 2. Number of injections needed to stop the bleeding episode. 3. Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective). 4. Participant's reported outcome as assessed by Euro QoL (EQ-5D). 5. Participant's reported outcome as assessed by Brief Pain Inventory. 6. Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire.;Timepoint(s) of evaluation of this end point: 1., 2. & 3.: 10 hours after each bleed 4. & 6.: 14 days after last exposure to BAY86-6150 5.: 7 days after last exposure to BAY86-6150 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Denmark, European Union, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed