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A Trial of YPEG-rhGH in Children With Short Stature

NCT05838885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-01-24

No results posted yet for this study

Summary

To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)).

To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.

Conditions

  • Idiopathic Short Stature
  • Small for Gestational Age
  • Turner Syndrome

Interventions

DRUG

YPEG-rhGH

YPEG-rhGH, 140μg/kg, s.c., once a week, for 52 weeks

DRUG

YPEG-rhGH

YPEG-rhGH, 280μg/kg, s.c., once a week, for 52 weeks

DRUG

rhGH

rhGH, 245μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks

DRUG

rhGH

rhGH, 470μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-10-23
Completion
2023-12-19

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 NCT05838885 on ClinicalTrials.gov