EUCTR2021-004313-39-SK招募中1 期
A Multicenter, Open-Label, Extension Trial to Investigate Long TermEfficacy and Safety of Lonapegsomatropin in Adults with GrowthHormone Deficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signing of the trial specific informed consent.
- •2. Completion of the treatment period and Visit 7 assessments of trial TCH-306, including
- •collection and upload of Visit 7 DXA scan.
- •3. Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension
- •or diabetic retinopathy stage 2 / moderate or above.
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Diabetes mellitus if any of the following are met:
- •a. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central
- •laboratory at Visit 6 in trial TCH-306
- •b. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-
- •4) inhibitors
- •2. Active malignant disease or history of malignancy. Exceptions are:
- •a. Resection of in situ carcinoma of the cervix uteri
- •b. Complete eradication of squamous cell or basal cell carcinoma of the skin
- •3. Known history of hypersensitivity and/or idiosyncrasy to the investigational product
- •(somatropin or excipients)
- •4. Female who is pregnant, plans to become pregnant, or is breastfeeding
- •5. Female participant of childbearing potential (i.e., fertile, following menarche and until
- •becoming post-menopausal unless permanently sterile) not willing throughout the trial to use
- •contraceptives as required by local law or practice. Details included in Appendix 4/section
- •10.4 of this protocol
- •6. Male participant not willing throughout the trial to use contraceptives as required by local
- •law or practice. Details included in Appendix 4/ section 10.4 of this protocol
- •7. Any disease or condition that, in the judgement of the investigator, may make the participant
- •unlikely to comply with the requirements of the protocol or any condition that presents undue
- •risk from the investigational product or trial procedures
- •8. eGFR <60 mL/min/1.73m² determined based on Modification of Diet in Renal Disease (MDRD) equation using serum creatinine from the central laboratory at screening
- •9. Hepatic transaminases (ie, AST or ALT) >3 times the upper limit of normal according to the central laboratory at screening
研究者
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