Short StatureNCT06768411
The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children
A study testing PEG-rhGH and GnRHa in people with Short Stature, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Short Stature
- What is being tested?
- PEG-rhGH and GnRHa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with short stature or a genetic target height below 2 standard deviations;
- Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
- Legal guardians consenting to participate in the study and signing informed consent forms.
Who cannot join
- Known or suspected hypersensitivity reactions to the investigational product or related products;
- Presence of severe systemic diseases;
- Patients with malignant tumors;
- Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
- Patients unable to adhere to follow-up or receive treatment as scheduled;
- Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.
- Conditions
- Short Stature
- Being tested
- PEG-rhGH, GnRHa
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhGHDrug
Also called 1, 2
1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH
GnRHaDrug
- pubertal children of short stature without GnRHa treatment
- pubertal children of short stature with GnRHa treatment
| Study group | Role | What they receive |
|---|---|---|
| prepubertal children of short stature | Other | prepubertal children of short stature with different Initial doses of PEG-rhGH Receives: Drug: PEG-rhGH |
| pubertal children of short stature | Other | pubertal children of short stature with different Initial doses of PEG-rhGH with or without GnRHa treatment Receives: Drug: PEG-rhGH; Drug: GnRHa |
What is being measured
The primary outcome is the main question the study is designed to answer.
height growth rate
Measure the height and observe how many centimeters it grows each month
Measured: 2 years
Secondary outcomes (2)
Sexual development status
Evaluate Tanner staging, The Tanner Staging, also known as Sexual Maturity Rating (SMR), is a classification system that healthcare providers use to document and track the development of secondary sex characteristics of children during puberty. It's a tool that outlines the stages of puberty for children and when they're likely to occur.
Measured: two years
IGF-1
IGF-1, known as insulin-like growth factor, is utilized to evaluate the efficacy of growth hormone therapy. By measuring IGF-1 levels, doctors can determine the effectiveness of the treatment and whether the patient's growth falls within the normal range
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768411
- Sponsor's protocol ID
- SAHoWMU-CR2024-06-223
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children
- ClinicalTrials.gov ID
- NCT06768411
- Acronym / sponsor ID
- SAHoWMU-CR2024-06-223
- Conditions
- Short Stature
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prepubertal children of short stature | Other | Drug: PEG-rhGHprepubertal children of short stature with different Initial doses of PEG-rhGH |
| pubertal children of short stature | Other | Drug: PEG-rhGH, Drug: GnRHapubertal children of short stature with different Initial doses of PEG-rhGH with or without GnRHa treatment |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with short stature or a genetic target height below 2 standard deviations;
- Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
- Legal guardians consenting to participate in the study and signing informed consent forms.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity reactions to the investigational product or related products;
- Presence of severe systemic diseases;
- Patients with malignant tumors;
- Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
- Patients unable to adhere to follow-up or receive treatment as scheduled;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhGHAlso: 1, 21= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH | Drug | prepubertal children of short stature, pubertal children of short stature |
| GnRHa1. pubertal children of short stature without GnRHa treatment 2. pubertal children of short stature with GnRHa treatment | Drug | pubertal children of short stature |
Primary outcome
height growth rate
Time frame: 2 years
Measure the height and observe how many centimeters it grows each month
2 secondary outcomes
Sexual development status
Time frame: two years
IGF-1
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhGH and GnRHa in people with Short Stature, run by Second Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoou Shan (+86 1377779922, 2296037178@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height growth rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.