NCT06025409招募中3 期
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
研究概览
简要总结
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
详细描述
The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
- •Diagnosis of central precocious puberty
- •For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
- •Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
- •In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent
排除标准
- •Following conditions at Visit 1(Screening) :
- •Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
- •requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
- •Prior treatment with GnRH analogues
- •Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
- •Prior or current therapy with growth hormone
- •has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine
- •Meets the following criteria based on screening test results:
- •AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years
- •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
研究组 & 干预措施
Experimental: Leuprorelin
Experimental
Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.
干预措施: Leuprolide Acetate 11.25 MG/ML (Drug)
结局指标
主要结局
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
时间窗: 6 months
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
次要结局
- Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.(3 months)
- Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.(Baseline, 3 and 6 months)
- Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration(3 and 6 months)
- Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.(Baseline, 3 and 6 months)
- Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.(6 months)
- Average Tanner Stage at 6 months after administration, and the changes compared to before administration.(6 months)
- Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.(6 months)
研究者
研究点 (1)
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