EUCTR2015-002337-22-AT进行中（未招募）1 期
Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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. Male or female, aged between 18 and 65 years.
- •2. Suspected growth hormone deficiency (GHD), based on either of the following:
- •- structural hypothalamic or pituitary disease, or
- •- surgery or irradiation in these areas, or
- •- head trauma as an adult, or
- •- evidence of other pituitary hormone deficiencies, or
- •- idiopathic childhood onset GHD (without known hypothalamic or pituitary lesion or injury).
- •OR (recruitment at dedicated trial sites only)
- •3. Group D: Healthy* control
- •Subject matching a Group A subject by
- •- sex, age (+/- 5 years), BMI (+/- 2 kg/m2), and estrogen status** (women only);
- •* ‘healthy’ comprising:
- •- history of normal growth and development,
- •- serum prolactin concentration within normal range limits,
- •- history of regular, age-appropriate menses in females
- •- serum testosterone concentration within normal range limits for males.
- •** matching for ‘estrogen status’:
- •- Group A subjects below 50 years and on oral estrogen therapy will be matched to control subjects who are also taking estrogen (as an oral contraceptive or for replacement); the route of estrogen administration (e.g. oral vs transdermal) must also be matched.
- •- Group A subjects 50 years or older and with untreated estrogen deficiency will be matched to female control subjects who are not receiving estrogen.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lack of suitability for the trial:
- •1. GH therapy within 1 month prior to anticipated first GHST within this trial (within 3 months in case of long-acting GH formulation).
- •Note: A patient with ongoing GH therapy will not be a candidate for this trial, if a corresponding treatment-free interval is not medically justifiable.
- •2. GHST within 7 days prior to the anticipated first test day within the trial.
- •3. Subjects with a medical history and clinical signs of a not adequately
- •treated thyroid dysfunction or subjects who had a change in thyroid therapy within 30 days prior to anticipated first test day within the trial.
- •4. Untreated hypogonadism or not on a stable substitution treatment within 30 days prior to anticipated first test day within the trial.
- •Note: Postmenopausal status will not be considered as an exclusion.
- •5. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levodopa, and dopamine agonists) or provoking the release of somatostatin; antimuscarinic agents (atropine).
- •6. Concomitant use of a CYP3A4 inducer (e.g., carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort).
- •7. Medical history of ongoing clinically symptomatic severe psychiatric disorders.
- •8. Parkinson’s disease.
- •9. Cushing disease or patients on supraphysiologic glucocorticoid therapy within 30 days prior to the anticipated first test day within the trial.
- •10. Type 1 diabetes or untreated or poorly controlled Type 2 diabetes, as defined by HbA1c > 8%.
- •11. Body mass index (BMI) = 40.0 kg/m2.
- •12. Participation in a trial with any investigational drug within 30 days prior to trial entry.
- •13. Vigorous physical exercise within 24 hours prior to each GHST within this trial.
- •Safety concerns:
- •14. Known hypersensitivity to macimorelin or insulin, or any of the constituents of either preparation.
- •15. Clinically significant cardiovascular or cerebrovascular disease.
- •16. Prolonged ECG QT interval, defined as QTc > 500 msec.
- •17. Concomitant treatment with any drugs that might prolong QT/QTc (see list of drugs at http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm (registration required), a copy of which is included in the Investigator’s File).
- •Note: A patient who receives such treatment will not be a candidate for this trial, if his/her condition does not allow for a treatment-free period of at least 5 elimination half-lives of the drug that might prolong QT/QTc before the GHST.
- •18. Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (ASAT, ALAT , GGT > 2.5 x ULN; creatinine, or bilirubin > 1.5x ULN).
- •19. Medical history of seizure disorders.
- •20. Known immunosuppression.
- •21. Current active malignancy other than non-melanoma skin cancer.
- •22. Breastfeeding or positive urine pregnancy test (for women of childbearing potential only).
- •23. Women of childbearing age without contraception, such as hormonal contraception or use of condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD).
- •Administrative reasons:
- •24. Lack of ability or willingness to give informed consent.
- •25. Anticipated non-availability for trial visits/procedures.
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