- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110910
Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)
Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)-an Open-label, Multicenter, Prospective and Retrospective Observational Study
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: xiaoping Luo, doctor
- Phone Number: 86 13387522645
- Email: xpluo@tjh.tjmu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- TongjiHospital
-
Contact:
- xiaoping Luo, doctor
- Phone Number: 86 13387522645
- Email: xpluo@tjh.tjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Children aged 2 years and older with various causes of short stature. 2. Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender.
3. Belonging to one of the following indications: GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, or other causes of short stature.
Exclusion Criteria:
1. Patients with fully closed growth plates. 2. Patients with signs of potential tumor progression or those already diagnosed with tumors.
3. Allergic reactions to growth hormone or its adjuvants. 4. Patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening.
5. Unable to provide complete medical records or expected to be unable to complete follow-up or collect complete medical records.
6. Any other circumstances deemed unsuitable for study inclusion by the investigator.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
prospective cohort
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
|
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
Other Names:
|
retrospective cohort
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
|
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
Other Names:
|
ambispective cohort
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
|
Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The AE (Adverse Event) and SAE (Serious Adverse Event) occurrence rates
Time Frame: From the time of signing the informed consent form to the near adult height(NAH), the overall assessment time was approximately 192 months.
|
An adverse event refers to any unfavorable medical occurrence in a patient after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug.
SAE, on the other hand, stands for serious adverse events, which encompass events such as patient death, life-threatening situations, permanent or severe disabilities or functional loss, hospitalization or extended hospital stays, as well as congenital anomalies or birth defects, among other adverse medical occurrences, following the administration of the investigational drug.
|
From the time of signing the informed consent form to the near adult height(NAH), the overall assessment time was approximately 192 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB202303156
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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