Hemophilia A MedDRA version: 9.1 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) MedDRA version: 9.1 Level: LLT Classification code 10018937 Term: Haemophilia A
Conditions
Interventions
Product Name: BAY 79-4980 (this product is discontined due to amendment 09)
Product Code: BAY 79-4980
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: octocog al
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males aged 12 to 70 years, inclusion of adolescent subjects will start after 20 adults have completed the run-in phase with acceptable tolerability and the DSMB has approved the start of recruitment of adolescent subjects Subjects with severe hemophilia A (0.6BU/mL is considered positive) in two consecutive samples and absence of clinical signs or symptoms of decreased response to FVIII administration. Subjects with no history of FVIII inhibitor antibody formation. (=0.6BU/mL using the Nijmegen-modified Bethesda assay) Subjects who complete an EPD (electronic patient diary) device training and demonstrate the ability to correctly use it Written informed consent by subject and parent / legal representative, if =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who are receiving primary prophylaxis (start of prophylaxis before or directly after the first joint bleed without relevant interruptions) 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 thrombocytopenia (platelets 2.0 mg/dL) Subjects with elevated hepatic transaminases within last 5 years prior enrollment(AST or ALT > 5xULN) Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study (the following drugs are allowed: interferon-alpha-treatment for HCV, HAART therapy for HIV and/or a total of two courses of pulse treatment with steroids for a maximum of 7 days at 1mg/kg or less) Subjects with an absolute CD4 lymphocyte cell count 100 mmHg) Subjects with known unstable coronary artery angina and/or with known history of myocardial infarction. Subjects who are unwilling to comply with study visits or the treatment regimens Subjects who have planned major surgery (including orthopedic) or radioisotopic synovectomy during the study Subjects who are not suitable for participation in this study for any reason, according to the Investigator Only for subjects who are participating in the PK sub-study: Subjects who are receiving any pegylated medication (e.g. PEG interferon) in the month prior to the PK session
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effect of a once-a-week prophylaxis regimen with BAY 79-4980 on the protection from total bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FS. ;Secondary Objective: The secondary objective is to evaluate the effect of a once-a-week prophylaxis regimen with BAY 79-4980 on the protection from joint bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FS.;Primary end point(s): The primary efficacy variable will be the percentage of subjects with less than 9 total bleeds per year. The three weeks run-in phase will not be considered for efficacy analyses. | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed