ClinicalTrials.gg
Not yet recruitingNCT06768411Updated Jan 10, 2025

The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children

An interventional study of PEG-rhGH and GnRHa in Short Stature, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
1 Year to 16 Years
Sex
All
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Study 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 hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.

02

Conditions studied

  • Short Stature

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03

In context

Dwarfism

99 studies on the registry are indexed under Dwarfism; 12 are open to participants now.

This study's planned enrollment of 240 is above the median of 60 across 66 interventional studies indexed under Dwarfism.

Browse Dwarfism studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with short stature or a genetic target height below 2 standard deviations;
  2. Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
  3. Legal guardians consenting to participate in the study and signing forms.

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected reactions to the product or related products;
  2. Presence of severe systemic diseases;
  3. Patients with malignant tumors;
  4. Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
  5. Patients unable to adhere to follow-up or receive treatment as scheduled;
  6. Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Other
    prepubertal children of short stature

    prepubertal children of short stature with different Initial doses of PEG-rhGH

    Drug: PEG-rhGH

  • Other
    pubertal children of short stature

    pubertal children of short stature with different Initial doses of PEG-rhGH with or without GnRHa treatment

    Drug: PEG-rhGH · Drug: GnRHa

Interventions

  • DrugPEG-rhGH

    1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH

    Also known as: 1, 2

  • DrugGnRHa

    1. pubertal children of short stature without GnRHa treatment 2. pubertal children of short stature with GnRHa treatment

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What researchers measure

Primary outcomes

  1. height growth rate

    Measure the height and observe how many centimeters it grows each month

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: two years

  2. 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

    Time frame: two years

Other outcomes

  1. bone age

    Bone age assessment

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06768411
Responsible party
Sponsor
First posted
Jan 10, 2025
Start date
Jan 15, 2025 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jan 10, 2025

Study contacts

Xiaoou Shan
Contact
2296037178@qq.com
+86 1377779922
Mengjie Yang
Contact
540718644@qq.com
+86 159 5871 0186

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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