A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for… (NCT03245333) | Clinical Trial Compass
UnknownPhase 3
A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
China120 participantsStarted 2014-12
Plain-language summary
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
Who can participate
Age range24 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of full-term small for gestational age, SGA.
* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
* Prepubertal stage (Tanner I).
* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
* A GH peak concentration \>10µg/L in a provocative test within a year before participating in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation:Fasting blood-glucose \< 5.6mmol/L, and 2 hours postprandial blood-glucose \< 7.8mmol/L.
* Gestational age was 37 to 42 weeks.
* The subjects and their guardians signed informed consent.
Exclusion Criteria:
* Subjects with Liver and renal insufficiency (ALT \> 1.5 times of upper limit of normal value, Cr\> upper limit of normal value).
* Patients are positive for antibodies to hepatitis B core (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
* Known Highly allergic constitution or allergic to the test drug.
* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
* Subjects with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
* Subjects who have received the treatment of GH.
* Subjects took part in other clinica…
What they're measuring
1
Change of height standard deviation score for chronological age (â–³Ht SDSCA)