New study tracks safety of clotting drug for hemophilia patients in india

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male patients aged 18 years or older with a documented diagnosis of severe Hemophilia A, defined by a baseline Factor VIII (FVIII) activity level of less than 1% (\<0.01 IU/mL) in accordance with the Hemophilia Severity Classification * Previously treated with FVIII concentrate(s) (plasma derived or recombinant, including Octocog alfa) either on-demand or prophylactically for at least 100 Exposure Days (EDs). * Patients for whom the decision to initiate on-demand treatment with Octocog alfa for acute bleeding was made as per the investigator's routine treatment practice. This will include patients who are already on on-demand treatment with Octocog alfa as well. * Written informed consent from the patient or legal representative Exclusion Criteria: * Known contraindication according to the local prescriber information * Patients who are participating in an investigational program with interventions outside of routine clinical practice. * Patients with any other diagnosis of bleeding/coagulation disorder other than Hemophilia A. * Patients who are on ongoing prophylactic treatment with any FVIII concentrate or non-factor treatments like emicizumab. * Patients exhibiting any of the following laboratory abnormalities at screening: * Known platelet count \<100,000 mm3 * Known Serum Creatinine \>2 folds upper the normal limit * Known Hepatic AST or ALT \>5 folds upper the normal limit * Patients who have received an on-demand infusion with any other FVIII (different to Octocog alfa), FVII or Activated prothrombin complex concentrate product (aPCC/FEIBA) 72 hours before the enrollment. * History or presence of FVIII inhibitor with a titer ≥ 0.6 with Nijmegen modified Bethesda Assay (NBA), or a clinical history suggestive of an inhibitor necessitating changes to treatment * Patient concerns or other barriers precluding adequate understanding or cooperation.