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

GeneScience Pharmaceuticals (GenSci)

Status: Completed

Conditions: Turner Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06722079

Gensci032-401

Details and patient eligibility

About

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.

Enrollment: 743 patients

Sex: Female

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

743 participants in 2 patient groups

PEG-rhGH injection

Description:

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

rhGH injection

Description:

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.