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NCT Number: NCT06768411

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

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.

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Key information

Conditions

Short Stature Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Musculoskeletal Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PEG-rhGH

Drug

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

Other names: 1, 2

GnRHa

Drug
  • pubertal children of short stature without GnRHa treatment
  • pubertal children of short stature with GnRHa treatment

Primary outcomes

  1. height growth rate

    Time frame: 2 years

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

Secondary outcomes

  1. Sexual development status

    Time frame: two years

    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.

  2. IGF-1

    Time frame: two years

    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

Other outcomes

  1. bone age

    Time frame: 2 years

    Bone age assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Mengjie Yang

CONTACT

[email protected]

+86 159 5871 0186

Xiaoou Shan

CONTACT

[email protected]

+86 1377779922

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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