A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly

Официальное название

A Randomized, Parallel, Open-label, Multicenter, Positive-controlled, Superiority Phase III Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly

Обзор

he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.

Подробное описание

This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study evaluating the efficacy and safety of octreotide long-acting injection in patients with acromegaly. The purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in treating acromegaly. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres(Sandostatin LAR®) cohort. A total of 154 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 28-week treatment period.

Вмешательства

• Препарат SYHX2008
  The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
• Препарат Sandostatin LAR®
  The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.

Первичные конечные точки

• The proportion of patients with an IGF-1 index ≤ 1.0 [Срок оценки: Week 28]

Вторичные конечные точки (12)

• The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0 [Срок оценки: weeks 4、8、12、16、20、24、28]
• The proportion of patients with GH less than 1.0 ng/mL and IGF-1 index less than or equal to 1.0 [Срок оценки: weeks 4、8、12、16、20、24、28]
• The proportion of patients with fasting GH < 1.0 ng/mL [Срок оценки: Weeks 4、8、12、16、20、24、28]
• The proportion of patients with fasting GH<2.5 ng/mL [Срок оценки: Weeks 4、8、12、16、20、24、28]
• The proportion of patients with an IGF-1 index ≤ 1.0 [Срок оценки: Weeks 4、8、12、16、20、24]
• The rate of change in the volume of the pituitary tumor from the baseline [Срок оценки: Weeks 28]
• The change in the total PASQ score from the baseline [Срок оценки: Weeks 12、28]
• The change in the total AcroQoL score from the baseline [Срок оценки: Weeks 12、28]
• The proportion of patients with fasting GH decreased by ≥50% compared to the baseline [Срок оценки: Weeks 4、8、12、16、20、24、28]
• The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline [Срок оценки: Weeks 4、8、12、16、20、24、28]
• Percentage changes in fasting GH from baseline [Срок оценки: Weeks 4、8、12、16、20、24、28]
• Percentage changes in IGF-1 from baseline [Срок оценки: Weeks 4、8、12、16、20、24、28]

Критерии участия

Критерии включения

• Male or female participants aged 18 to 80 years (including boundary values)
• Diagnosed with acromegaly, currently in the active stage of the disease (for patients who have not undergone pituitary tumor surgery before, MRI shows a pituitary mass, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3; for patients who have undergone pituitary tumor surgery, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3)；

Критерии исключения

• Have received pituitary radiotherapy within the 5 years prior to screening
• Have undergone major surgery (including pituitary surgery) within 6 months prior to screening or are expected to require surgery (including pituitary surgery) or radiotherapy during the study period
• Within three months before the screening, participants received drugs such as long-acting lanretide, long-acting octreotide, pervesomone, and cabergoline, or traditional Chinese medicines for treating acromegaly. Receive bromocriptine within one month before screening; Received short-acting octreotide or lanretide short-acting preparations for treatment within 7 days before screening; Or have received any other investigational drug within 30 days before screening or within 5 half-lives (whichever is longer)
• Previous failure to respond to octreotide or lantreotide monotherapy (defined as: after at least 3 months of treatment with octreotide microspheres ≥30 mg or lantreotide ≥120 mg, or after at least 3 months of treatment with parietide microspheres ≥40 mg, random GH ≥2.5 ng/mL and/or IGF-1 index ≥1.3) or history of intolerance.
• Participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention
• HbA1c>8.5%

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07623824 · SYHX2008-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗