NCT05029622已完成3 期
A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 66
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Luteinising Hormone (LH) Suppression
研究概览
简要总结
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent.
- •Participant must present evidence of CPP documented by:
- •Onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II) before the age of 8 years in girls and 9 years in boys.
- •Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) in both sexes.
- •Difference between bone age (BA) and CA >1 year.
- •Girls with Tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter >4 mm in the ovary observed by pelvic type B ultrasound at the Screening visit; boys who have testicular volume ≥4 mL observed by testicular orchidometer at the Screening visit.
- •Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period.
排除标准
- •Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
- •Non-progressing isolated premature thelarche.
- •Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
- •Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.
研究组 & 干预措施
Triptorelin formulation for Intramuscular injection (IM).
Experimental
干预措施: Triptorelin Pamoate (Drug)
结局指标
主要结局
Percentage of Participants With Luteinising Hormone (LH) Suppression
时间窗: At Month 6
LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
次要结局
- Percentage of Participants With LH Response to GnRH Test(At Months 3 and 12)
- Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels(Baseline and at Months 3, 6, 9 and 12)
- Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test(Baseline and at Months 3, 6 and 12)
- Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12(Month 6 to Month 12)
- Change From Baseline in Growth Velocity(Baseline and at Months 6 and 12)
- Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen(At Months 6 and 12)
- Percentage of Participants With Prepubertal Levels of Sex Steroids(At Months 3, 6, 9 and 12)
- Change From Baseline in Mean Height for Age (Z-Score)(Baseline and at Months 6 and 12)
- Change From Baseline in Percentile for Height for Age(Baseline and at Months 6 and 12)
- Change From Baseline in BA:CA Ratio(Baseline, Months 6 and 12)
- Percentage of Participants With Stabilized Pubertal Stage(At Months 6 and 12)
- Percentage of Participants With Regression of Uterine Length(At Months 6 and 12)
- Change From Baseline in Body Mass Index (BMI)(Baseline and at Months 6 and 12)
- Plasma Concentrations of Triptorelin(Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12)
- Percentage of Participants With Absence of Progression of Testis Volumes(At Months 6 and 12)
- Change From Baseline in Weight(Baseline and at Months 6 and 12)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
3 期
Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the ProstateProstate CancerNCT05458856Ipsen147
已完成
3 期
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate CancerProstate CancerNCT01656161Debiopharm International SA120
已完成
3 期
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up StudyPrecocious PubertyNCT00909844Ipsen35
已完成
3 期
Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate CancerProstate CancerNCT01715129Ipsen126
已完成
3 期
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious PubertyCentral Precocious PubertyNCT01467882Debiopharm International SA44