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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Stage 1:JINTOPIN AQ 0.2IU/kg/d(0.46mg/kg /wk)for 52 weeks.
Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe first affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Change of height standard deviation score for chronological age (△Ht SDSCA)
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
Time frame: 52 weeks
Height(Ht)at the end of treatment
Time frame: Stage 1:52 weeks
Height(Ht)at the end of treatment
Time frame: Stage 2:Every 52 weeks, up to 3 years
Annualized height velocity (HV)
Time frame: Stage 1:52 weeks
Annualized height velocity (HV)
Time frame: Stage 2:Every 52 weeks, up to 3 years
Bone age maturation
Time frame: Stage 1:52 weeks
Bone age maturation
Time frame: Stage 2:Every 52 weeks, up to 3 years
Mole ratio of IGF-1 and IGFBP-3
Time frame: Stage 1:52 weeks
Mole ratio of IGF-1 and IGFBP-3
Time frame: Stage 2:Every 52 weeks, up to 3 years
IGF-1 standard deviation score (SDS)
Time frame: Stage 1:52 weeks
IGF-1 standard deviation score (SDS)
Time frame: Stage 2:Every 52 weeks, up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Children's Hospital, Capital Medical University
Beijing, China
RECRUITINGShanghai Children's Hospital
Shanghai, China
RECRUITING