EUCTR2014-004493-42-Outside-EU/EEA进行中（未招募）不适用
A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate theEfficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulationsin Children with Central Precocious Puberty
Abbvie previously known as Abbott0 个研究点目标入组 80 人开始时间: 2014年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The informed consent form, assent form and any privacy statement (e.g., HIPAA)
- •must be approved by a local or central Institutional Review Board (IRB) as
- •required by State and local regulations. Prior to performing any trial-related
- •procedures, each subject's parent must review, understand, and sign an informed
- •consent form. When determined to be appropriate (as specified either by the IRB
- •and/or State and local regulations), each subject must also sign the assent form
- •after having had an opportunity to review the form and have its contents explained
- •and questions answered.
- •2. Subject has a clinical diagnosis of CPP.
- •3. Eligible to receive at least 6 months of therapy to treat CPP after study entry.
- •4. Chronological age at onset of pubertal symptoms less than 8 years old in girls and
- •less than 9 years old in boys at Day 1.
- •5. Bone age advanced at least 1 year beyond the chronological age at time of
- •diagnosis or first GnRHa therapy.
- •6. In general good health with no uncontrolled, clinically significant disease which
- •would interfere with bone maturation or mask the objectives of this protocol as
- •assessed by the investigator.
- •Additional criteria for subjects naïve to GnRHa treatment:
- •7. Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1
- •8. Pretreatment pubertal response to leuprolide acetate stimulation (LH = 8 mIU/mL)
- •at Screening.
- •9. Breast pubertal staging of at least II in Girls; testicular volume of at least 4cc or
- •testicular length greater than 2.5 cm in Boys at Screening.
- •Additional criteria for subjects previously treated with GnRHa:
- •10. Girls 2-10 years inclusive or Boys 2-11 years inclusive at Day 1.
- •11. Must have been on standard GnRHa therapy for at least the 6 months prior to
- •to the end of their previous GnRHa treatment cycle.
- •12. Should have documented maintenance of LH suppression as evidenced by peak
- •stimulated LH < 4 mIU/mL at Screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 84
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Incomplete precocious puberty (premature thelarche, premature adrenarche).
- •2. Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal
- •hyperplasia, testotoxicosis in boys, hCG secreting tumor or McCune-Albright
- •syndrome in girls.
- •3. Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal
- •function other than premature secretion of gonadotropins not adequately
- •controlled.
- •4. Unstable intracranial tumors (unresponsive to treatment/expanding) except
- •5. Previous treatment with GnRHa therapy requiring leuprolide acetate for depot
- •suspension > 15 mg monthly.
- •6. Bone age > 13 years for girls and > 14 years for boys.
- •7. Any other condition interfering with growth, i.e., skeletal dysplasia, cerebral palsy.
- •8. Chronic illness requiring treatment that may interfere with growth, i.e., chronic
- •steroid use, renal failure, moderate to severe scoliosis.
- •9. Diagnosis of short stature, i.e., more than 2.25 SD below the mean height for age
- •(growth chart measurement).
- •10. Prior or current therapy with medroxyprogesterone acetate.
- •11. Prior or current therapy with growth hormone.
- •12. Subject has an abnormal laboratory value that suggest a clinically significant
- •underlying disease or condition that may prevent the subject from entering the
- •study or subject with the following laboratory abnormalities: Creatinine
- •> 1.5 mg/dL, ALT and/or AST > 2.0 × ULN, or total bilirubin > 2.0 mg/dL with
- •AST/ALT elevated above normal limits.
- •13. Subject has a positive pregnancy test.
- •14. Any concomitant medical condition that, in the opinion of the investigator, may
- •expose a subject to an unacceptable level of safety risk or that affects subject
- •compliance.
- •15. Known hypersensitivity to study medication or its excipients.
- •16. Subject is a family member of the investigator, sub investigator, or study
- •coordinator. Family member is defined to include either a child (including step or
- •foster child), niece, nephew, sibling or cousin.
- •17. Participation in another drug research within 3 months of randomization into this
- •18. Prior or current therapy with IGF-1.
- •19. Use of an estrogen preparation within 2 months prior to Day 1.
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