EUCTR2015-001878-18-DK进行中（未招募）1 期
A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (corifollitropin alfa) in Combination with human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old with hypogonadotropic hypogonadism (Phase III; Protocol No. MK-8962-043-00) - MK-8962 in adolescent males 14 to <18 years old with hypogonadotropic hypogonadism (HH)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
入选标准
- •1. Have a legal representative who understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to the subject’s participation by giving written informed consent, and the subject has an age-appropriate understanding of the same to give informed written assent if applicable (i.e., in accordance with local requirements). Subjects with an illiterate legal representative may be included if, in the opinion of the investigator, the legal representative fully understands the risks of the subject’s participation and provides consent. In addition, the legal representative may also consent to (and in accordance with local requirements, the subject may assent to) have the subject participate in Future Biomedical Research by signing a separate consent.
- •2. Be male.
- •3. Be 14 to <18 years of age at the time when consent/assent is signed, with treatment to begin prior to the subject’s 18th birthday.
- •4. Have been diagnosed with hypogonadotropic hypogonadism (either isolated or associated with panhypopituitarism), either congenital or acquired with onset prior to puberty.
- •5. Have bilateral pre-gonadarche testes as defined by testicular volume <4.0 mL for each testicle, as determined by ultrasound and assessed by the investigator (if qualified) or local radiologist with appropriate training and expertise in reading testicular ultrasound. Note: subjects with a volume of <4.0 mL in one testicle and a volume of 4-8 mL in the other testicle are considered to be pre-gonadarche and may participate, if there is no history or evidence of a primary testicular disorder (see Exclusion Criteria 1 and 2).
- •6. Have circulating levels of Total T less than the lower limit of normal (LLN) of 8.3 nmol/L as specified by the central lab for a young healthy adult male.
- •7. Have FSH < or = 2 IU/L and LH < or = 2 IU/L.
- •8. Have inhibin-B levels < or = 35 pg/mL.
- •9. Be in good general physical and mental health, in the opinion of the investigator/sponsor, as assessed by physical examination and routine clinical laboratory tests.
- •10. Have a parent/guardian able and willing to support the subject’s participation by supporting adherence to study drug dosing and visit schedules.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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. Has a history of bilateral cryptorchidism (maldescended testes) or unilateral cryptorchidism treated after the age of 2 years.
- •2. Has a history or presence of clinically significant testicular problems (e.g., epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy, occlusive azoospermia, etc.) that in the opinion of the investigator would impair the subjects response to treatment or has had known damage or injury to the vas deferens.
- •3. Has had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens (e.g., testosterone, etc.).
- •4. Has an untreated or inadequately treated pituitary or hypothalamic tumor.
- •5. Has uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary disorders not on stable replacement therapies (i.e., subject has not been on stable doses for at least 3 months).
- •6. Has a history of active pituitary hypersecretion as evidenced by hyperprolactinemia or Cushing’s disease, or acromegaly, or any other active pituitary hypersecretion syndrome.
- •7. Has had hypophysectomy within a period of 12 months prior to the start of screening.
- •8. Has history of oncologic chemotherapy treatment.
- •9. Has had brain radiotherapy within 12 months of the start of treatment for a primary tumor, or any history of brain radiotherapy for metastatic disease.
- •10. Has diabetes mellitus.
- •11. Has a history of Human Immunodeficiency Virus (HIV).
- •12. Has renal insufficiency as determined by the investigator based on serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate.
- •13. Has clinically significant liver disease, including active viral hepatitis or cirrhosis. Subjects with a prior history of liver disease which is now inactive or successfully treated may be enrolled if all liver function values (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin) performed within the past year have been normal and are within the normal range (per central lab) at V1. Liver function testing may be repeated once prior to allocation of treatment at the discretion of the investigator if results are inconsistent with the subject’s clinical status or recent laboratory results.
- •14. Has had a recent history (i.e., within 1 year prior to signing the informed consent) of recreational (e.g., for non-medical purposes) or illicit drug use, including marijuana; or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
- •15. Adecuate organ function laboratory values in accordance with the current protocol.
- •16. Has an allergy/sensitivity to gonadotropins or its/their excipients.
- •17. Has any clinically significant condition or situation that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
- •18. Has used an investigational drug and/or participated in any other clinical trial within the past 8 weeks (prior to V2), or will participate in any other clinical trials (excluding surveys) during the course of this trial.
- •19. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigatio
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