Идёт набор NCT04655092

Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

Фаза III С лечением Polycythemia Vera (PV)

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: В протоколе указаны: P1101 (Ropeginterferon alfa-2b).
Кому может быть актуально: Состояния в реестре: Polycythemia Vera (PV). Базовые параметры: от 20 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: Япония
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

Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)

Обзор

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

Подробное описание

The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.

Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.

Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.

Вмешательства

Биопрепарат P1101 (Ropeginterferon alfa-2b)
The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.

Первичные конечные точки

Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks [Срок оценки: Through study completion, an average of 2 year]

Вторичные конечные точки (8)

Changes in hematocrit every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]
Changes in white blood cell every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]
Changes in platelet count every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]
Changes in red blood cell count every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]
Changes in spleen size every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]
Necessity of phlebotomy [Срок оценки: Through study completion, an average of 2 year]
Proportion of subjects without thrombotic or hemorrhagic events [Срок оценки: Through study completion, an average of 2 year]
Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time [Срок оценки: Through study completion, an average of 2 year]

Критерии участия

Критерии включения

Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
Patients who have given written informed consent to participate in this study