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Status unknownNCT03290235Updated Dec 12, 2017

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

A Phase 4 interventional study of PEG-somatropin in Growth Retardation, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 42 Months to 15 Years. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
1,500
Allocation
Non-randomized
Ages
42 Months to 15 Years
Sex
All
01

Study summary

  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.
02

Conditions studied

  • Growth Retardation
03

Who can participate

Ages eligible
42 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    PEG-somatropin-1

    Dosage 0.2mg/kg/w

    Drug: PEG-somatropin

  • Experimental
    PEG-somatropin-2

    Dosage 0.1-0.2mg/kg/w

    Drug: PEG-somatropin

Interventions

  • DrugPEG-somatropin

    Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit

    Also known as: Jintrolong®

05

What researchers measure

Primary outcomes

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

    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

    Time frame: Baseline, every 13 weeks until 130 weeks

Secondary outcomes

  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

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

    Time frame: Baseline, every 13 weeks until 130 weeks

06

Study locations

1 of 1 sites recruiting
  • TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology
    Wuhan, Hubei, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03290235
Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Mar 1, 2017
Primary completion
Oct 2020 (estimated)
Completion
Sep 2021 (estimated)
Last update
Dec 12, 2017

Study contacts

Xiaohua Feng
Contact
fengxiaohua@gensci-china.com
0431-85170552

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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