Идёт набор NCT07583563
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
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: Octreotide subcutaneous depot.
- Кому может быть актуально
- Состояния в реестре: Acromegaly. 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
A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly
Обзор
The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
Вмешательства
- Препарат Octreotide subcutaneous depot
Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study
Первичные конечные точки
- Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information. [Срок оценки: From enrollment to the end of treatment at 2 years]
Вторичные конечные точки (9)
- Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Change in proportion of participants with IGF-1 ≤1×ULN over time. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Change in GH levels over time. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Change in proportion of participants with GH levels <1.0 μg/L over time. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Changes in symptoms of acromegaly over time, as measured by the Acromegaly Index of Severity (AIS) scale. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL). [Срок оценки: From enrollment to the end of treatment at 2 years]
- Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). [Срок оценки: From enrollment to the end of treatment at 2 years]
- Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire. [Срок оценки: From enrollment to the end of treatment at 2 years]
- Incidence of octreotide SC depot non-related AEs and incidence of laboratory abnormalities using the CTCAE grading scale. [Срок оценки: From enrollment to the end of treatment at 2 years]
Критерии участия
Критерии включения
- Have started or will be starting treatment with octreotide SC depot for acromegaly
Критерии исключения
- Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly
- Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 5 центров
- Universitaetsklinikum Aachen — Aachen
- Universitaetsklinikum Leipzig — Leipzig
- Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie — Magdeburg
- Medicover Neuroendokrinologie MVZ — München
- Universitätsklinikum Würzburg — Würzburg
Идентификаторы
NCT: NCT07583563 · HS-24-799