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Analysis of Efficacy and Safety of Pegylated-Recombinant Human Growth Hormone (PEG-rhGH) in the Treatment of Prepubertal Children with Short Stature (SS) across Different BMI Categories

Analysis of Efficacy and Safety of Pegylated-Recombinant Human Growth Hormone (PEG-rhGH) in the Treatment of Prepubertal Children with Idiopathic Short Stature (ISS) across Different BMI Categories

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114064
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Short stature

Interventions

Normal BMI group:None
High BMI group:None

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Age: Girls aged 3-12 years and boys aged 3-13 years (inclusive of the boundary values); 2. At the time of screening, the child's height must be 2 standard deviations (SD) or more below the average height for normal children of the same age and gender, or below the 3rd percentile (P3, -1.88 SD), and must be diagnosed as a short child; 3. Children must be before the peak of puberty, specifically in Tanner Stage I; 4. The child must not have received growth-promoting treatment previously and must be planning to undergo growth hormone treatment; 5. The guardian must understand and sign the informed consent form. For subjects aged 8 years or older, the informed consent form must also be signed by them. For subjects under 8 years old who are capable of expressing consent, their consent should be clearly documented.

Exclusion criteria

Exclusion criteria: Any of the following conditions will disqualify a participant from this study: 1. Patients with contraindications or allergies to the study drug or its components; 2. Patients with any of the following conditions that render them unsuitable for growth hormone treatment: (1) A history of malignant tumors; (2) Other endocrine system diseases such as diabetes and hypothyroidism; (3) Liver or kidney dysfunction (ALT > 2 times the upper limit of normal, and/or Cr > 2 times the upper limit of normal); (4) Other conditions that are unsuitable for growth hormone treatment, including Turner syndrome, pubertal delay due to constitutional factors, Laron syndrome, and growth hormone receptor deficiency; 3. Complete closure of the epiphysis; 4. Congenital skeletal abnormalities, scoliosis, or limping; 5. Participation in other interventional clinical studies within 3 months prior to screening.

Design outcomes

Primary

MeasureTime frame
Height standard deviation score;

Secondary

MeasureTime frame
Height growth rate;Insulin-like growth factor-1;Bone age;

Countries

China

Contacts

Public ContactXueyan Wang

The Second Hospital of Tianjin Medical University

wxy1008@126.com+86 159 2212 4200

Outcome results

None listed

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