NCT02830477已完成不适用
A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 313
- 试验地点
- 13
- 主要终点
- Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
研究概览
简要总结
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.
In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
详细描述
Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
- •≥ 50 exposure days (EDs) to any FVIII product
- •Patients with or without history of inhibitors
- •Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
- •No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
- •Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay [<0.6 Bethesda units (BU/mL)] or Bethesda assay [< 1.0 BU/mL] in 2 on consecutives samples
- •Documented or clinical suspicion of shortened FVIII half-life (< 6 hrs)
- •Currently on or plan to start prophylaxis therapy with KOVALTRY
- •Written informed consent
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
- •Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
结局指标
主要结局
Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
时间窗: Up to 2 years
次要结局
- Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)(Up to 2 years)
- Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)(At baseline, 1 year and end of observational period, up to 2 years)
- Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)(At baseline, 6 months and end of observational period, up to 2 years)
- The total annualized factor consumption (injections)(Up to 2 years)
- Proportion of patients in predefined prophylaxis regimen per age group and per country(At the end of observational period, up to 2 years)
- Physician decision determinants of prophylaxis regimen(At baseline)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Up to 2 years)
- Type of data relating to KOVALTRY PK(At routine visits, up to 2 years)
- Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)(At baseline and end of observation period, up to 2 years)
- Change in prophylaxis dosing frequency (study start to end of observation period)(At baseline and end of observation period, up to 2 years)
- Number of KOVALTRY PK assessments performed(At routine visits, up to 2 years)
研究者
研究点 (13)
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