Skip to content

Trial · Interventional

Status unknownPhase 4Registry data

Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

NCTNCT03290235 (opens ClinicalTrials.gov in a new tab)Other idGenSci 045 CT-Extension Period
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
1,500 participants (estimated)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

China

Start
1 Mar 2017
Primary completion
Oct 2020 (estimated)
Completion
Sept 2021 (estimated)
First posted
21 Sept 2017
Last update posted
12 Dec 2017
Conditions
Growth Retardation

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 4

    Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

    NCT03290235

    1 Mar 2017 to est. Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.

Interventions

  • PEG-somatropinDrug

Arms2

  • Experimental

    PEG-somatropin-1

    Dosage 0.2mg/kg/w

  • Experimental

    PEG-somatropin-2

    Dosage 0.1-0.2mg/kg/w

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ht SDSca (Height standard deviation score for chronological age)

    Time frame · Baseline, every 13 weeks until 130 weeks

    Registry description

    Calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age

Secondary outcomes(5)

  1. Ht SDSBA (Height standard deviation score for bone age)

    Time frame · Baseline, every 13 weeks until 130 weeks

  2. Yearly growth velocity

    Time frame · Baseline, every 13 weeks until 130 weeks

  3. IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)

    Time frame · Baseline, every 13 weeks until 130 weeks

  4. Bone age

    Time frame · Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks

  5. Near final height for some subjects

    Time frame · Baseline, every 13 weeks until 130 weeks

    Registry description

    When yearly growth velocity of some subject is no more than 2cm/year.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHou L, Huang K, Gong C, Luo F, Wei H, Liang L, Du H, Zhang J, Zhong Y, Chen R, Chen X, Pan J, Jin X, Zeng T, Liao W, Liu D, Lan D, Zhu S, Dong Z, Ma H, Yang Y, Xiong F, Lu P, Cheng S, Gu X, Jin R, Liu Y, Wu J, Xu X, Chen L, Dong Q, Pan H, Su Z, Liu L, Luo X, Ni S, Chen Z, Hu Y, Wang C, Liu J, Liu L, Lu B, Wang X, Wang Y, Yang F, Zhang M, Cao L, Liu G, Yao H, Zhan Y, Dai M, Li G, Li L, Liu Y, Wang K, Xiao Y, Zhang X, Dong J, Gu Z, Ying L, Huang F, Liu Y, Liu Z, Ye J, Zhao D, Hu X, Jiang Z, Ye K, Zhu H, Chen S, Chen X, Wan N, Xu Z, Yin Q, Zhang H, Huang X, Yin J, Zhang H, Li P, Yin P, Fu J, Luo X. Long-term Pegylated GH for Children With GH Deficiency: A Large, Prospective, Real-world Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):2078-2086. doi: 10.1210/clinem/dgad039. PMID 36669772

Eligibility

Who could join, as posted.

Sex
All
Age
from 42 Months up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Children has completed all visits and therapy in previous phase IV study; * Investigators evaluate subjects could continue growth hormone therapy; * Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. Exclusion Criteria: * Children with epiphyseal closure; * Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys; * Dysfunction of liver and kidney (ALT\> 2 times the upper limit of normal, Cr\> upper limit of normal); * Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other components of the study product; * Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * Patients with diabetics; * Patients with congenital bone dysplasia or scoliosis; * Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study; * Other conditions in which the investigator preclude enrollment into the study.

PepBank is a research reference. Talk to a doctor before you use any peptide.