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Growth Retardation

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

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.

About this trial

Last updated 8 years ago

Study ID

GenSci 045 CT-Extension Period

Status

Unknown status

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
42 to 15 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.