EUCTR2021-004313-39-GR进行中（未招募）1 期
A Multicenter, Open-Label, Extension Trial to Investigate Long TermEfficacy and Safety of Lonapegsomatropin in Adults with GrowthHormone Deficiency
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
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
- •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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