growth hormone deficiency(GHD)
Conditions
Interventions
Exposed group (PEG-rhGH):None
Sponsors
Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1.Male and female, aged from 3 to 13 years, weighing less than 40kg; 2.Bone age: male =14 years old, female =13 years old; 3.The height of children at screening was below the 3rd percentile (-1.88SD) or -2SD for the same chronological age and sex; 4.The growth rate was less than 7 cm/year in the year before screening (< 3 years old). <5 cm/year (3 years old to prepubertal); <6 cm/year (adolescence); 5.In the year prior to screening, both different growth hormone stimulation tests, using two distinct stimulants, had peak concentrations of less than 10 µg/L (ng/ml); 6.Treatment with pegylated recombinant human growth hormone (PEG-rhGH) was confirmed at screening; 7.Never had received previous growth-promoting therapy, including but not limited to growth hormone, insulin-like growth factor, sex hormones, and aromatase inhibitors; 8.Participants and guardians were willing and able to cooperate with scheduled visits, treatment planning, and laboratory testing procedures, and signed consent form voluntarily;
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity reactions to the study intervention or related drugs; 2.Patients with current or previously diagnosed malignant tumor; 3.Diagnosed with other types of growth and development disorders, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age with short stature, and growth retardation caused by malnutrition; 4.Congenital skeletal dysplasia or scoliosis (scoliosis Angle =15 degrees, or moderate to severe scoliosis requiring treatment), claudication. 5.Diagnosed diabetes; 6.Children with hypothyroidism and/or adrenal insufficiency had not received adequate stable replacement therapy lasting at least 90 days at the time of screening; 7.Participants who had participated in any other clinical trial within 3 months before screening and had received pharmacologic or nonpharmacologic interventions; 8.Other conditions that were considered by the investigator to be ineligible for inclusion in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety index;Height;IGF-1;Bone age; | — |
Countries
China
Contacts
Public ContactCheng Xinran
Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Outcome results
None listed