Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
研究概览
简要总结
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
详细描述
This pharmacokinetic profile will be obtained in only in patient using Advate® (INN-octocog alfa) or Adynovi® (INN- rurioctocog alfa pegol), both recombinant intravenous FVIII products, with myPKFiT®. This patients will be followed during the period of 12 months, and the pharmacokinetic will be measured collecting at least 2 blood samples, in which the presence of factor VIII will be determined by the usual clinical methods: chromogenic method or coagulative method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients.
- •Age between 1 and 65 years old.
- •Patients diagnosed with Hemophilia A who are on prophylactic treatment with Advate® or Adynovi® or adjusted with myPKFIT.
- •Patients older than 18 who have signed the informed consent form.
- •In the case of mature minors, in addition to the consent signed by the legal guardian, an assent of the minor must be obtain.
- •In the case of patients legally incapable for giving their consent, their primary caregiver will consent as the patient's legal guardian.
排除标准
- •Withdrawal of informed consent.
- •Patients with any medical or psychological condition that according to the researcher's criteria prevents them from following the usual clinical practice procedures.
- •Patients with concomitant diagnosis of other haemostasis disorders.
- •Patients being treated for induction of immunologic tolerance at the time of inclusion.
研究组 & 干预措施
Hemophilia A patients
Group of patients in prophylactic treatment with Advate® (octocog alfa) or Adynovi® (rurioctocog alfa pegol), or patients using already myPKFit®.
Patients will be given a dose of octocog alfa or rurioctocog alfa pegol according to usual clinical practice, and two blood samples will be taken in case of octocog alfa: one sample will be extracted 3-4h postdose (+/- 30 minutes), and the second sample will be extracted 24-32h postdose (+/- 60 minutes). In case of rurioctocog alfa pegol, the first sample is taken in the same conditions than octocog alfa, and the second sample will be extracted 48h postdose (+/- 120 minutes), and other sample post 72h(+/- 120 minutes) optional.
干预措施: octocog alfa (Drug)
Hemophilia A patients
Group of patients in prophylactic treatment with Advate® (octocog alfa) or Adynovi® (rurioctocog alfa pegol), or patients using already myPKFit®.
Patients will be given a dose of octocog alfa or rurioctocog alfa pegol according to usual clinical practice, and two blood samples will be taken in case of octocog alfa: one sample will be extracted 3-4h postdose (+/- 30 minutes), and the second sample will be extracted 24-32h postdose (+/- 60 minutes). In case of rurioctocog alfa pegol, the first sample is taken in the same conditions than octocog alfa, and the second sample will be extracted 48h postdose (+/- 120 minutes), and other sample post 72h(+/- 120 minutes) optional.
干预措施: rurioctocog alfa pegol (Drug)
结局指标
主要结局
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
时间窗: 72 hours postdose
Change from Baseline to 12 months
Pharmacokinetic profile: Clearance measured with MyPKFiT
时间窗: 72 hours postdose
Change from Baseline to 12 months
Pharmacokinetic profile: Volume in steady state measured with MyPKFiT
时间窗: 72 hours postdose
Change from Baseline to 12 months
次要结局
- Self-adherence to treatment evaluation(month 12)
- Hemorrhagic risk of physical activity(month 12)
- Number of total bleeding episodes in a year(month 12)
- Annual Joint Bleeding Record(month 12)
- Joint condition(month 12)
- Adverse Events(month 12)