Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study

This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.). To gather the data during the predefined visit of the study, a booklet will be filled by the designated physician. The primary objective of this study is to evaluate the immunogenicity profile of Coageight by assessing the prevalence of factor VIII inhibitors in the study population, as determined by a positive Bethesda assay. The sample size of the study is set at 262 patients.

Inclusion criteria

• Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
• Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
• History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion

Exclusion criteria

• History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)
• Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments
• Participation or intent to participate in another research study during this study period
• Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)