NCT06743035招募中不适用
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Symptom Burden
研究概览
简要总结
The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed diagnosis of PV without symptomatic splenomegaly
- •Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC
- •No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolled up to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be on treatment at the time of enrollment.)
- •Dated signature of informed consent form
- •Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment
- •Other criteria according to current Summary of Product Characteristics
排除标准
- •Participation in an interventional clinical trial (except follow-up)
- •Other contraindications according to current Summary of Product Characteristics
结局指标
主要结局
Symptom Burden
时间窗: From Time of enrollment until month 36.
Absolute values of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS) at time of study enrollment, during course of study until month 36.
次要结局
- Effectiveness: Complete hematologic response (CHR) rate(From time of treatment start until end of study (max. 54 months after FPI))
- Effectiveness: Event-free survival (EFS)(From time of treatment start until end of study (max. 54 months after FPI))
- Effectiveness: Proportion of patients with platelet count ≤400 ×109/L(From time of treatment start until end of study (max. 54 months after FPI))
- Effectiveness: Proportion of patients with WBC count <10 ×109/L(From time of treatment start until end of study (max. 54 months after FPI))
- Effectiveness: Proportion of patients with HCT value <45%(From time of treatment start until end of study (max. 54 months after FPI))
- Effectiveness: Proportion of patients without phlebotomy during course of study(From time of treatment start until end of study (max. 54 months after FPI))
- Drug safety(From time of treatment start until end of study (max. 54 months after FPI))
- Dosing(From start until end of treatment (max. 54 months after FPI))
- Treatment discontinuation(From start until end of treatment (max. 54 months after FPI))
- (S)ADRs leading to permanent treatment discontinuation(From start until end of treatment (max. 54 months after FPI))
- Symptom burden(From time of enrollment until month 36 after treatment start (max. 54 months after FPI))
- Treatment reality: previous cytoreductive therapies(From time of treatment start until end of study (max. 54 months after FPI))
- Treatment reality: Switch to ropeginterferon alfa-2b(From time of treatment start until end of study (max. 54 months after FPI))
- Treatment reality: parallel cytoreductive therapies(From time of treatment start until end of study (max. 54 months after FPI))
- Treatment reality: subsequent cytoreductive therapies(From time of treatment start until end of study (max. 54 months after FPI))
研究者
研究点 (1)
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