Idiopathic short stature
Conditions
Interventions
PEG-rhGH group:None
rhGH Groups:None
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1.Age: Females 3 to 8 years old (inclusive), males 3 to 9 years old (inclusive); 2.Diagnosis: Height at screening below -2.0 standard deviations (SD) or below the 3rd percentile (-1.88 SD) for chronological age and sex, with a diagnosis of Idiopathic Short Stature (ISS); 3.Pubertal Status: Prepubertal children (Tanner stage I). 4.Growth Hormone (GH) Status: Serum GH peak level >= 10 ng/ml (µg/L) confirmed by any GH stimulation test within one year prior to screening. 5.Treatment History: No prior growth-promoting therapy and planned initiation of growth hormone treatment. 6.Informed Consent: Legal guardian(s) must understand and provide written informed consent. Additionally, subjects aged 8 years or older must also provide assent. If subjects under 8 years old are capable of expressing agreement, their assent must be formally documented.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to planned growth hormone; 2. The presence of any of the following diseases that are not suitable for growth hormone therapy: (1) history of malignant tumor (2) diabetes mellitus (3) hepatic or renal insufficiency (ALT > 2 times of the upper limit of normal, P 2 times the upper limit of normal) (4) other diseases that are not suitable for growth hormone therapy, such as heart, liver, kidney and other important organ dysfunction, systemic infection or immunocompromised diseases; 3. The epiphysis was completely closed; 4. Congenital skeletal dysplasia or scoliosis or claudication; 5. Participated in other interventional clinical trials within 3 months before screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Age;Change in standard deviation of height growth rate (HV);The medication compliance was evaluated by the subjects' medication diary card;Changes in bone age/chronological age (BA/CA);Insulin-like growth factor 1 standard deviation score (IGF-1 SDS);Incidence of adverse events (AE) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactJiangfeng Mao
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed