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A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

NCT07260500 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-17

No results posted yet for this study

Summary

This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.

Conditions

  • Short Stature Children Born Small for Gestational Age (SGA)

Interventions

DRUG

PEG-rhGH Injection

Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..

DRUG

hGH Injection

Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-12-23
Completion
2027-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260500 on ClinicalTrials.gov