Clinical Trials

Inclusion Criteria:

- 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 DXA scan.

- Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial
hypertension or diabetic retinopathy stage 2 / moderate or above.

Exclusion Criteria:

- Diabetes mellitus if any of the following are met:

1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to
central laboratory at Visit 6 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. Exceptions are:

1. Resection of in situ carcinoma of the cervix uteri;

2. Complete eradication of squamous cell or basal cell carcinoma of the skin.

- Known history of hypersensitivity and/or idiosyncrasy to the investigational product
(somatropin or excipients).

- Female who is pregnant, plans to become pregnant, or is 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.

- Male participant not willing throughout the trial to use contraceptives as required by
local law or practice. 

- 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.

Eligibility last updated 3/31/22. Questions regarding updates should be directed to the study team contact.