Набор по приглашению NCT05796440

A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

Фаза II С лечением Growth Hormone Deficiency

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: LUM-201.
Кому может быть актуально: Состояния в реестре: Growth Hormone Deficiency. Базовые параметры: 5 лет — 14 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: США, Австралия
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

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency

Обзор

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Подробное описание

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.

There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.

Вмешательства

Препарат LUM-201
Administered orally once daily

Первичные конечные точки

Incidence of treatment-emergent adverse events [Срок оценки: Day 1 to Month 36]

Вторичные конечные точки (6)

Growth Hormone Concentrations in subjects [Срок оценки: Day 1 to Month 36]
Insulin-like growth factor 1 concentration [Срок оценки: Day 1 to Month 36]
Height standard deviation score (SDS) [Срок оценки: Day 1 to Month 36]
Change in Weight SDS [Срок оценки: Day 1 to Month 36]
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201 [Срок оценки: Day 1 to Month 36]
Change in Bone Age (BA) [Срок оценки: Day 1 to Month 36]

Критерии участия

Критерии включения

Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.
Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met.

Критерии исключения

Medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to the use of LUM-201
Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет