Clinical trial: Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency (NCT04326374)

Eligibility criteria:
Inclusion Criteria:

          -  Prepubertal children with GHD in Tanner stage 1, aged of 3 years and below 17 years;

          -  Impaired HT defined as at least 2.0 standard deviations (SD) below the mean height for
             chronological age and sex (HT SDS≤-2.0) according to the Chinese 2005 standard；

          -  Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH
             level of ≤10 ng/mL, determined with a validated assay. Bone age (BA) at least 6 months
             less than the chronological age；

          -  Baseline IGF-1 level of at least 1.0 SD below the mean IGF-1 level standardized for
             age and sex (IGF-1 SDS ≤-1.0)；

          -  Written, signed informed consent of the parent(s) or legal guardian(s) of the subject
             and written assent of the subject (if the subject is 8 years old or above).

        Exclusion Criteria:

          -  Children with a body weight below 12 kg；

          -  Prior exposure to recombinant hGH or IGF-1 therapy；

          -  Children with past or present intracranial tumor growth as confirmed by a sellar MRI
             scan (with contrast dye recommended) at Screening

          -  Children born SGA (birth weight ≤10th percentile for gestational age according to the
             Chinese reference)；

          -  Children with psychosocial dwarfism；

          -  Children with idiopathic short stature；

          -  Other causes of short stature such as coeliac disease, hypothyroidism, or rickets；

          -  History or presence of malignant disease; any evidence of present tumor growth;

          -  Subjects with diabetes mellitus；

          -  Closed epiphyses；

          -  Major medical conditions and/or presence of contraindication to hGH treatment；

          -  Participation in any other trial of an investigational agent within 3 months prior to
             Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 17 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? 0