EUCTR2018-001989-42-DE进行中（未招募）1 期
Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial
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
- 100
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
- •Subjects are eligible to be included in the trial only if all of the following criteria apply:
- •1. Informed consent of subject, parent(s) or legally acceptable representative (LAR) of subject and child assent, if appropriate, must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •2. Male and female pediatric subjects from 2 to less than 18 years of age at the time of signing informed consent.
- •3. Indication for the performance of growth hormone stimulation test.
- •4. Presence of a height measurement minimum 6 and maximum 18 months prior to screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •Subjects are excluded from the trial if any of the following criteria apply:
- •Lack of suitability for the trial:
- •1. Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with short stature (e.g., Turner syndrome, skeletal dysplasia’s, celiac disease, etc.).
- •2. Ongoing growth hormone therapy.
- •3. Presence of hypothyroidism and/or adrenal insufficiency without adequate and stable replacement therapy treatment for at least 30 days prior to first GHST.
- •4. 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 e.g., atropine).
- •5. Medical history of ongoing clinically symptomatic psychiatric disorders.
- •6. 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds, prolongation of the QTc interval over 450 milliseconds, or any
- •other clinically significant abnormal electrocardiogram results at the screening
- •ECG as judged by the investigator.
- •7. Previous participation in this trial. Participation is defined as signed informed consent.
- •8. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
- •Safety concerns:
- •9. Known or suspected hypersensitivity to trial product(s) or related products;
- •10. Any disorder, which in the investigator’s opinion might jeopardize subject’s safety or compliance with the protocol.
- •11. Concomitant treatment with any drugs that might prolong QT/QTc
- •Note: A subject who receives such treatment will not be a candidate for this study, 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;
- •12. Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (AST, ALT, GGT > 2.5 x ULN; creatinine or bilirubin > 1.5x ULN);
- •13. Current active malignancy other than non-melanoma skin cancer;
- •14. Female of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- •15. Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- •Administrative reasons:
- •16. Lack of ability or willingness to give informed consent by the subject and/or his/her legal representative;
- •17. Anticipated non-availability for trial visits/procedures.
- •Amendment for Germany:
- •18. Prepubertal boys >11 years and in prepubertal girls >10 years who would need to undergo sex steroid priming before a GHST.
研究者
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