Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027
研究概览
简要总结
This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). Both drugs are FVIII products which have been manufactured via recombinant technology and have an extended half-live, i.e. they will stay longer in the body than other FVIII products. Therefore these products act longer in the body which reduces the frequency of drug injections. To compare the two drugs, a cross-over design was chosen, i.e. each patient will receive both products one after another.
Patients participating in this study will receive one dose of Jivi and one dose of Adynovi. Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood samples will be taken from the participants to measure the blood levels of FVIII. Generic name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants with severe hemophilia A (baseline FVIII activity FVIII:C <1%), determined by measurement at the time of screening (following a washout period of at least 72 h after their last FVIII treatment for standard half-life FVIII products or of 120 h for extended half-life FVIII products) or from reliable prior documentation (e.g. measurement in other clinical studies, result from approved clinical laboratory or diagnostic genetic testing).
- •≥150 exposure days with FVIII concentrate(s) (plasma-derived or recombinant) as supported by medical records.
- •Body mass index (BMI) within the range 18 kg/m2 to 29.9 kg/m2 (inclusive).
排除标准
- •Inability to stop FVIII treatment to complete a minimum of 72 h washout for standard half-life FVIII product or 120 h washout for extended half-life FVIII product
- •Evidence of current or past inhibitor antibody
- •History of any congenital or acquired coagulation disorders other than hemophilia A
- •Platelet count <75,000/mm3
- •Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3
- •Abnormal renal function (serum creatinine >2x the upper limit of the normal range [ULN])
- •Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
- •Requirement of any pre-medication to tolerate FVIII treatment (e.g. anti-histamines)
- •Prior treatment with immunomodulatory agents or chemotherapy within the last 3 months prior to study entry or requirement of treatment during the study. The following drugs are allowed: α interferon, PEG interferon, highly active anti-retroviral therapy for HIV, and/or a total of two courses of pulse treatment with steroid for a maximum of 7 days at 1 mg/kg or less
结局指标
主要结局
Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027
时间窗: Pre-dose to 120 hours after the end of the infusion
Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi
时间窗: Pre-dose to 120 hours after the end of the infusion
次要结局
未报告次要终点