A Real-world Study of Long-acting Growth Hormone Injection for Turner Syndrome

Completed

• Conditions: Turner Syndrome

• Registration Number: NCT06722079
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Primary Completion: 2023-06-05
• Study Completion: 2023-06-05
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 743

Inclusion Criteria

• Patients diagnosed with Turner syndrome by a clinician;
• The first treatment was short-acting rhGH, and the first administration date was not earlier than July 1, 2008;
• Follow-up data are available at the center before the first dosing and after at least one dosing.

Exclusion Criteria

● None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).	Week 52	Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).

Secondary Outcome Measures

Name	Time	Method
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.	Week 52	The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.

Trial Locations

Locations (1)

Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology; 🇨🇳 Wuhan, Hubei, China