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

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ClinicalTrials.gov Identifier: NCT03290235
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Growth Retardation Drug: PEG-somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: PEG-somatropin-1
Dosage 0.2mg/kg/w
Drug: PEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
Other Name: Jintrolong®

Experimental: PEG-somatropin-2
Dosage 0.1-0.2mg/kg/w
Drug: PEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
Other Name: Jintrolong®




Primary Outcome Measures :
  1. Ht SDSca (Height standard deviation score for chronological age) [ Time Frame: Baseline, every 13 weeks until 130 weeks ]
    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 Outcome Measures :
  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 ]
    When yearly growth velocity of some subject is no more than 2cm/year.



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Ages Eligible for Study:   42 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290235


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

Locations
China, Hubei
TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology Recruiting
Wuhan, Hubei, China
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03290235     History of Changes
Other Study ID Numbers: GenSci 045 CT-Extension Period
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs