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Long-term efficacy and safety evaluation of growth hormone in children in China-an open, multicenter, prospective and retrospective observational study

Long-term efficacy and safety evaluation of growth hormone in children in China-an open, multicenter, prospective and retrospective observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070431
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood dwarfism (including GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletions and other etiological dwarfs)

Interventions

case series:NA

Sponsors

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Retrospective cohort: (1) Children aged 2 years and above with different causes of short stature; (2) Height lower than the third percentile of height of normal healthy children of the same age and sex (-1.88SD); (3) Patients who have received PEG-rhGH or rhGH treatment for more than 1 year and have now finished treatment, and belong to one of the following indications: 1) The first queue: GHD; 2) The second queue: ISS; 3) The third queue: SGA; 4) The fourth queue: TS; 5) The fifth queue: PWS; 6) The sixth queue: NS; 7) The seventh cohort: SHOX gene deletion and other causes of dwarfism. 2. Review prospective cohorts: (1) The patient's parents or legal guardians must read, understand and sign the informed consent, and the patient with reading ability must read (or be read to) and sign the child informed consent; (2) Children aged 2 years and above with different causes of short stature; (3) Height lower than the third percentile of height of normal healthy children of the same age and sex (-1.88SD); (4) PEG-rhGH or rhGH is being used and belongs to one of the following indications: 1) The first queue: GHD; 2) The second queue: ISS; 3) The third queue: SGA; 4) The fourth queue: TS; 5) The fifth queue: PWS; 6) The sixth queue: NS; 7) The seventh cohort: SHOX gene deletion and other causes of dwarfism. 3. Prospective cohort: (1) The patient's parents or legal guardians must read, understand and sign the informed consent, and the patient with reading ability must read (or be read to) and sign the child informed consent; (2) Children aged 2 years and above with different causes of short stature; (3) Height lower than the third percentile of height of normal healthy children of the same age and sex (-1.88SD); (4) PEG-rhGH or rhGH is required and is one of the following indications: 1) The first queue: GHD; 2) The second queue: ISS; 3) The third queue: SGA; 4) The fourth queue: TS; 5) The fifth queue: PWS; 6) The sixth queue: NS; 7) The seventh cohort: SHOX gene deletion and other causes of dwarfism.

Exclusion criteria

Exclusion criteria: 1. Patients whose epiphysis has been completely closed; 2. Retrospective cohort of patients treated with PEG-rhGH or rhGH for less than 1 year; prospective cohort of patients who had and expected to use PEG-rhGH or rhGH for less than 1 year; prospective cohort of PEG-rhGH or rhGH for less than 1 year; 3. Potential tumor patients and diagnosed tumor patients with any signs of progress; 4. Patients who are allergic to growth hormone or its protective agents; 5. Within 6 months before screening, the patient had received any growth hormone treatment other than the study drug; 6. Unable to provide complete medical records or not expected to be able to follow up or collect complete medical records; 7. Any other situation that the researcher thinks is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
Validity;

Countries

China

Contacts

Public ContactLuo Xiaoping

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

xpluo@tjh.tjmu.edu.cn+86 27 83663712

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026