An observational study in Turner Syndrome, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to female participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Observational
This study is divided into two parts:
Part A: A multicenter, retrospective, observational study to evaluate the effectiveness of PEG-rhGH in the treatment of Turner syndrome with domestic real-world data on rhGH as external controls. The collection and arrangement of real world data is the content of the real world study (RWS); Part B: Meta analysis (MA) was conducted based on the previous literatures on rhGH in the treatment of Turner syndrome, and MA results were used as external controls to evaluate the effectiveness of PEG-rhGH.
Real-world data on rhGH treatment of Turner syndrome in China were obtained from the HIS system and/or paper medical records of participating domestic centers and/or photocopied/printed medical records of other hospitals. Data on the efficacy of PEG-rhGH injection in the treatment of Turner syndrome were obtained from the 0.2mg /kg/ week group in the Phase II clinical trial of PEG-rhGH injection in the treatment of Turner syndrome (multicenter, randomized, blank control, superior efficacy) conducted by Changchun GeneScience Pharmaceutical Co., Ltd (Protocol number: GenSci032-02, version date: April 27, 2015). The MA study data of rhGH in the treatment of Turner syndrome in foreign countries came from the relevant literature retrieved from the approved drug database of FDA, PubMed and Web of Science database.
115 studies on the registry are indexed under Turner Syndrome; 33 are open to participants now.
This study's enrollment of 743 is above the median of 125 across 63 observational studies indexed under Turner Syndrome.
Browse Turner Syndrome studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The indication in this study is Turner syndrome, which only occurred in females.
Exclusion Criteria:
● None.
The group of Turner syndrome patients treated with a dose of 0.2 mg/kg/ week in GenSci032-02 clinical trial.
Part A control group: a group of Turner syndrome patients treated with rhGH who met the inclusion criteria of the RWS study population from participating research centers in China. Part B control group: studies of rhGH treatment for Turner syndrome performed abroad that met all MA inclusion criteria and did not meet any MA exclusion criteria.
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
Time frame: Week 52
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.
Time frame: Week 52
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Changchun GeneScience Pharmaceutical Co., Ltd.