NCT05493709已完成3 期
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 64
- 主要终点
- Efficacy of Leuprolide Mesylate (FP-001 42 mg)
研究概览
简要总结
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
详细描述
This is a multi-center, open-label, single-arm study. All subjects will be pediatric patients with central precocious puberty judged to be candidates for GnRH (gonadotropin releasing hormone) analog therapy, and all will receive two injections of FP-001 42 mg six-month apart in an unblinded fashion.
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
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
- •Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
- •Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation > 5 mIU/mL.
- •Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
- •Willing and able to participate in the study.
- •Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
- •Bone age < 13 years for girls and < 14 years for boys.
- •Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the custodial parent(s) or by the legal guardian(s) (if required).
- •Signed Assent by patients as per IRB/IEC requirements.
排除标准
- •Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. This includes true CPP triggered by other conditions, such as congenital adrenal hyperplasia.
- •Prior or current GnRH treatment for CPP.
- •Non-progressing isolated premature thelarche.
- •Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Patients with hamartomas or adenomas not requiring surgery are eligible.
- •Any other condition, chronic illness or treatment that, in the opinion of the Investigator, may interfere with growth or other study endpoints (e.g., chronic steroid use [except mild topical steroids], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
- •Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
- •Major medical or psychiatric illness that could interfere with study visits.
- •Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
- •Positive urine pregnancy test.
- •Known hypersensitivity to GnRH or related compounds.
- •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study.
- •Any other condition(s) which could significantly interfere with Protocol compliance.
- •Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0).
- •Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions.
- •Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per Investigator opinion, have been associated with seizures or convulsions.
研究组 & 干预措施
FP-001 42 mg
Experimental
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
干预措施: Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide (Drug)
结局指标
主要结局
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
时间窗: 48 weeks
The percentage of patients with serum LH concentrations \< 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
次要结局
- Effect of FP-001 42 mg on bone age progression(24 and 48 weeks)
- Effect of FP-001 42 mg on suppression of physical signs of puberty(48 weeks)
- Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH(48 weeks)
- Effect of FP-001 42 mg on growth rate(48 weeks)
- Effect of FP-001 42 mg on physical signs of puberty(48 weeks)
研究者
研究点 (64)
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