Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.

Study Overview

• Status: Unknown
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Biological: PEG-somatropin; Biological: PEG-somatropin

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Children's Hospital affiliated to Capital Institute of Pediatrics
    • Beijing, Beijing, China
      • Recruiting
      • Chinese Academy of Medical Sciences &Peking Union Medical College
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
    • Wuxi, Jiangsu, China
      • Recruiting
      • Affiliated Hospital, Jiangnan University
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • First Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Children's Hospital of Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Children's Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Second University Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

  • According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
  • Height velocity (HV) ≤5.0 cm/yr.
  • GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
  • Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
• Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
• Receive no prior GH treatment within 6 months.
• Sign informed consent.

Exclusion Criteria:

• People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
• Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
• People with known highly allergic constitution or allergy to the drug of the study.
• People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
• Diabetic.
• Potential tumor patients (family history).
• Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
• Subjects took part in other clinical trial study within 3 months.
• Other conditions which in the opinion of the investigator preclude enrollment into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG-somatropin; 0.12mg/kg/w	Biological: PEG-somatropin; 0.20mg/kg/w; Biological: PEG-somatropin; 0.12mg/kg/w
EXPERIMENTAL: PEG-Somatropin; 0.20mg/kg/w	Biological: PEG-somatropin; 0.20mg/kg/w; Biological: PEG-somatropin; 0.12mg/kg/w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSca	Ht SDSca was 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	Baseline, 4,12,26 weeks after initiating treatment

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (ESTIMATE): March 5, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary
• Other Study ID Numbers: GenSci 004 CT-2