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

Last updated: December 10, 2017
Sponsor: GeneScience Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

4

Condition

Williams Syndrome

Growth Hormone Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT03290235
GenSci 045 CT-Extension Period
  • Ages 42-15
  • All Genders

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.

Eligibility Criteria

Inclusion

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, treatmentplans and laboratory tests and other procedures, to sign informed consent.

Exclusion

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> upperlimit of normal);

  • Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any othercomponents of the study product;

  • Patients with severe cardiopulmonary or hematological diseases, a current or pasthistory 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-Somatropinafter phase IV study and before screening for this extension study;

  • Other conditions in which the investigator preclude enrollment into the study.

Study Design

Total Participants: 1500
Study Start date:
March 01, 2017
Estimated Completion Date:
September 30, 2021

Connect with a study center

  • TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology

    Wuhan, Hubei
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.