A Phase 2 interventional study of PEG-somatropin in Dwarfism, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Active, not recruiting at 12 sites in China. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.
99 studies on the registry are indexed under Dwarfism; 12 are open to participants now.
This study's planned enrollment of 360 is above the median of 60 across 66 interventional studies indexed under Dwarfism.
Browse Dwarfism studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Subjects who have taken the following medications within 2 months before entering the extension period study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for the high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
Drug: PEG-somatropin
After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
Also known as: Polyethylene Glycol Recombinant Human Somatropin Injection
Change of yearly height velocity (ΔHV)
Change of yearly height velocity before and after treatment. Yearly Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline)(Yx refers to the height value at particular timepoint x)
Time frame: Baseline，the end of 3-year addendum
Standard deviation score of height at the actual age (ΔHT SDS)
Standard deviation score of height at the actual age.
Time frame: Baseline，every 3 months，the end of 3-year addendum
Change fo Bone maturation
Change fo Bone maturation before and after treatement (bone age/chronological age)
Time frame: Baseline，every 3 months，the end of 3-year addendum
Change of IGF-1 SDS (ΔIGF-1 SDS)
Change of IGF-1 SDS before and after treatement
Time frame: Baseline，every 3 months，the end of 3-year addendum
Changes of standard deviation scores of body mass index (ΔBMI SDS)
Changes of standard deviation scores of body mass index
Time frame: Baseline，every 3 months，the end of 3-year addendum
The yearly average dose of PEG-rhGH injection
Time frame: Baseline，every 3 months，the end of 3-year addendum
Final height (FH)
Final height
Time frame: Baseline，every 3 months，the end of 3-year addendum
The improvement of FH compared with the baseline predicted adult height (PAH)
Time frame: Baseline，every 3 months，the end of 3-year addendum
Improvement of NAH (near adult height)
For subjects who reach NAH with treatment but fail to follow-ups before reaching FH, the improvement of NAH in comparison with the baseline PAH (predicted adult height) shall be evaluated
Time frame: Baseline，every 3 months，the end of 3-year addendum
the improvement of PAH
For subjects who fail to reach NAH with treatment and fail to follow-ups before reaching FH, the improvement of PAH in comparison with the baseline PAH shall be evaluated
Time frame: Baseline，every 3 months，the end of 3-year addendum
The changes of the scores evaluated by the Quality of Life Scale
Time frame: Baseline，every 3 months，the end of 3-year addendum
The changes of lean body mass (LBM) (optional)
Time frame: Baseline，every 3 months，the end of 3-year addendum
The changes of fat mass (torso) (FM) (optional)
Time frame: Baseline，every 3 months，the end of 3-year addendum
The changes of the percentage of body fat (optional)
Time frame: Baseline，every 3 months，the end of 3-year addendum
The changes of bone mineral density (BMD) (optional)
Time frame: Baseline，every 3 months，the end of 3-year addendum
Started May 2017 (actual). Primary completion is estimated for Jun 2030, 157 months after the start.
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Growth Hormone
Changchun GeneScience Pharmaceutical Co., Ltd. →