An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24
研究概览
简要总结
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.
详细描述
The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP.
The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration:
• Leuprorelin Acetate Depot 3M 11.25 mg
Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination.
This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.
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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
- •Body weight ≥20 kg
- •According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level >5.0 IU/L with LH/FSH >0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening.
排除标准
- •The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
- •The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
- •The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
- •The participant has a diagnosis of peripheral precocious puberty.
研究组 & 干预措施
Leuprorelin Acetate Depot 3M 11.25 mg
Participants with CPP having body weight greater than equal to (≥)20 kilograms (kg) received the recommended dose of leuprorelin acetate depot 11.25 milligrams (mg) subcutaneous administration (SC) every 12 weeks based on the standard of 30～180 micrograms (μg)/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg.
干预措施: Leuprorelin Acetate Depot 3M (Drug)
结局指标
主要结局
Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24
时间窗: Week 24
The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).
次要结局
- Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24(Baseline and Week 24)
- Percentage of Participants With Tanner Stage Regression or No Progression at Week 24(Baseline and Week 24)
- Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)(Baseline, Weeks 24 and 36)
- Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24(Baseline and Week 24)
- Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24(Baseline and Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (TEAE)(From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks))