Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ascendis Pharma Endocrinology Division A/S
Age
23–81
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signing of the trial specific informed consent
Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 dual-X-ray-absorptiometry (DXA) scan
Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above
You may not be if
Diabetes mellitus if any of the following were met:
1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
Active malignant disease or history of malignancy.
Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
Female who was pregnant, plans to become pregnant, or was breastfeeding
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 the protocol
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 the protocol
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
Clareo Health | A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
