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

NCT ID: NCT06722079

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 743 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2023-06-05

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.

Conditions

Turner Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

PEG-rhGH injection

The group of Turner syndrome patients treated with a dose of 0.2 mg/kg/ week in GenSci032-02 clinical trial.

No interventions assigned to this group

rhGH injection

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

xiaoping Luo, Doctor

Role: STUDY_CHAIR

Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology

Locations

Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

Gensci032-401

Identifier Type: -

Identifier Source: org_study_id