phase 3 efficacy and safety study of bax 855 in severe hemophilia a patients undergoing surgical procedures

Conditions: Hemophilia A

Summary: the purpose of the study is to evaluate the efficacy and safety of bax 855 in severe hemophilia a previously treated (ptp) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.


Eligibility criteria:
inclusion criteria: * participant requires an elective major or minor surgical, dental or other invasive procedure (e.g. biopsy, endoscopy). * participant and/or legal representative has/have provided signed informed consent. * participant has severe hemophilia a (factor viii (fviii) level \<1%) as confirmed by the central lab at screening or a documented fviii activity level \<1%. * participant was previously treated with fviii concentrates with ≥150 documented exposure days (eds). * participant is currently receiving prophylaxis or on-demand therapy with fviii concentrate. * participant has a karnofsky performance score of ≥60 at screening. * participant is human immunodeficiency virus negative (hiv-); or hiv+ with stable disease and cd4+ count ≥200 cells/mm\^3, as confirmed by central laboratory at screening. * participant is hepatitis c virus negative (hcv-) by antibody or pcr testing (if positive, antibody titer will be confirmed by pcr), as confirmed by central laboratory at screening; or hcv+ with chronic stable hepatitis as assessed by the investigator. * participant is willing and able to comply with the requirements of the study protocol. exclusion criteria: * participant has detectable fviii inhibitory antibodies (≥0.4 bethesda unit (bu) using the nijmegen modification of the bethesda assay) at screening as determined by the central laboratory or at any timepoint prior to screening (≥0.4 bu using the nijmegen modification of the bethesda assay or ≥0.6 bu using the bethesda assay). * history of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (dic). * participant has a platelet count \<100 x 10\^9/l, as confirmed by central laboratory at screening. * participant has severe renal impairment (serum creatinine \> 2.0 mg/dl), as confirmed by central laboratory at screening. * participant has severe chronic hepatic dysfunction (eg ≥5 x upper limit of normal alanine aminotransferase (alt), as confirmed by the central laboratory at screening, or a documented international normalized ratio (inr) \> 1.5). * participant has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to peg. * participant is currently using or has recently (\< 30 days) used pegylated drugs (other than bax 855) prior to study participation or is scheduled to use such drugs during trial participation. * participant is currently participating in another clinical drug (other than bax 855) or device study or use of another investigational product or device within 30 days prior to study entry. * participant has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia a. * participant is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (eg, systemic corticosteroid agent at a dose equivalent to hydrocortisone \>10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy. * participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.