Идёт набор NCT06743035

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

— Наблюдательное Polycythemia Vera

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Polycythemia Vera. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany

Обзор

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.

Первичные конечные точки

Symptom Burden [Срок оценки: From Time of enrollment until month 36.]

Вторичные конечные точки (12)

Effectiveness: Complete hematologic response (CHR) rate [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Effectiveness: Event-free survival (EFS) [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Effectiveness: Proportion of patients with platelet count ≤400 ×109/L [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Effectiveness: Proportion of patients with WBC count <10 ×109/L [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Effectiveness: Proportion of patients with HCT value <45% [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Effectiveness: Proportion of patients without phlebotomy during course of study [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Drug safety [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]
Dosing [Срок оценки: From start until end of treatment (max. 54 months after FPI)]
Treatment discontinuation [Срок оценки: From start until end of treatment (max. 54 months after FPI)]
(S)ADRs leading to permanent treatment discontinuation [Срок оценки: From start until end of treatment (max. 54 months after FPI)]
Symptom burden [Срок оценки: From time of enrollment until month 36 after treatment start (max. 54 months after FPI)]
Treatment reality: previous cytoreductive therapies [Срок оценки: From time of treatment start until end of study (max. 54 months after FPI)]

Критерии участия

Критерии включения

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