Evaluation of Patient and Physician Reported Reasons for Switching FVIII Replacement Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life
研究概览
简要总结
This US study will assess hemophilia A patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A: 1) patients who have switched from conventional therapy to new FVIII products with an improved PK profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new FVIII products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for patients/caregivers in the Patient/Caregiver Study:
- •Patients with hemophilia A (≥ 18 years of age) or caregivers of children with hemophilia A (≥12-<18 years of age)
- •Group 1: Hemophilia A patients/caregivers who have switched to FVIII products with improved half-life for the treatment of hemophilia A during the eligibility period. These patients can also include those who have switched back from FVIII products with improved half-life to conventional FVIII replacement therapy within the Data Collection Period
- •Group 2: Hemophilia A patients/caregivers who are considering switching to FVIII products with improved half-life within 12 months of the Start of the Documentation period and have been prescribed prophylaxis regimen of at least 2x/week
- •Able to understand, read, write and speak English
- •Provide electronic informed consent
- •Able to access the Internet for at least 20 minutes per day during the Data Collection Period
- •Inclusion criteria for physicians:
- •At least 60% of time spent in direct patient care
- •Board-certified or eligible with a Specialty in Hematology or Hematology-Oncology
- •Physicians with a specialty in Hematology-Oncology must have at least 10% of their practice dedicated to treatment of hemophilia
- •A minimum of 2 years' experience treating hemophilia A patients
- •Inclusion criteria for patients in the physician chart study:
- •Hemophilia A patients age 12 year and over
- •Prior treatment with one of the following FVIII replacement products: Adynovate, Afstyla, Eloctate, or Kovaltry
- •Patients that have 12 months of medical chart data available; 6 months on conventional therapy and 6 months after switching to FVIII products with improved half-life.
排除标准
- •Exclusion criteria for patients/caregivers in the Patient/Caregiver Study:
- •Hemophilia A patient initiated FVIII products with improved half-life for the treatment at time of diagnosis with hemophilia A.
- •Exclusion criteria for physicians:
- •Unwilling to comply with the study protocol
研究组 & 干预措施
FVIII products (prospective)
Qualitative patient/caregiver study:
Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
干预措施: FVIII products (Drug)
FVIII products (prospective)
Qualitative patient/caregiver study:
Hemophilia A patients/caregivers (N=30) having initiated a FVIII products with improved half-life
干预措施: Conventional FVIII replacement therapies (Drug)
Conventional FVIII replacement therapies
Qualitative patient/caregiver study:
Hemophilia A patients/caregivers (N=30) receiving "conventional" FVIII replacement therapy for at least 6 months who are considering switching to a FVIII product with improved half-life within the next 1 year
干预措施: Conventional FVIII replacement therapies (Drug)
FVIII products (retrospective)
Quantitative physician interview/ chart review study:
Hemophilia A patients (N=100) who have switched from "conventional" FVIII replacement therapy to FVIII products with improved half-life.
干预措施: FVIII products (Drug)
FVIII products (retrospective)
Quantitative physician interview/ chart review study:
Hemophilia A patients (N=100) who have switched from "conventional" FVIII replacement therapy to FVIII products with improved half-life.
干预措施: Conventional FVIII replacement therapies (Drug)
结局指标
主要结局
The clinical characteristics of patients who switch from conventional FVIII replacement therapy to FVIII products with improved half-life
时间窗: Up to 4.5 months
A retrospective patient medical chart review
The changes of treatment characteristics from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
时间窗: Up to 4.5 months
A retrospective patient medical chart review
The obstacles of switching among hemophilia A patients who did not switch from conventional therapy to FVIII products with improved half-life but who are open to switching
时间窗: Up to 6 days
These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes' worth of questions per day.
The reasons of patients/caregivers "switch" from conventional FVIII replacement therapy to FVIII products with improved half-life
时间窗: Up to 6 days
These patients/caregivers will participate in an asynchronous online discussion forum consisting of predetermined open ended and close ended questions for a series of 6 consecutive days completing approximately 20 minutes' worth of questions per day.
The changes of bleeding related outcomes from 6 months prior to switching compared to 6 months after switching from conventional FVIII replacement therapy to FVIII products with improved half-life
时间窗: Up to 4.5 months
A retrospective patient medical chart review
The reasons for switching from conventional FVIII replacement therapy to FVIII products with improved half-life, from the physician perspective
时间窗: Up to 4.5 months
A retrospective patient medical chart review
次要结局
未报告次要终点