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.).
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
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)
A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)
Cohort
Cross-sectional
efmoroctocog alfa
DrugThis study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment.
Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)
Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test
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This trial is not recruiting at the moment. You can still explore other options:
