A Cross-sectional, Observational, Multi-center Study to Assess the Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight (rFVIII-Fc, Manufactured by AryoGen Pharmed Co.)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 262
- 试验地点
- 6
- 主要终点
- Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)
研究概览
简要总结
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.).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.)
干预措施: efmoroctocog alfa (Drug)
结局指标
主要结局
Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)
时间窗: 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
次要结局
未报告次要终点