Hemophilia A, Hemophilia
Conditions
Keywords
Factor VIII, Coageight, Prevalence, Immunogenicity, Recombinant Factor VIII with Fc Fusion, Hemophilia A
Brief summary
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.).
Detailed description
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.
Interventions
This 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.
Sponsors
AryoGen Pharmed Co.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
2 Years to No maximum
Inclusion criteria
1. Male patients aged 2 years or older with a signed informed consent by them or their legal guardian 2. Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion 3. 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
1. 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) 2. Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments 3. Participation or intent to participate in another research study during this study period 4. Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.) | Day 0 (-7 to 0 days) | Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test |
Countries
Iran
Contacts
CONTACTHamidreza Kafi, Clinical Pharmecy Ph.D
Outcome results
None listed