Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
PD
Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study
1 other identifier
interventional
101
0 countries
N/A
Brief Summary
The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedJuly 31, 2017
May 1, 2011
8 months
April 21, 2011
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth velocity
25 weeks
Secondary Outcomes (3)
height standard deviation score for chronological age (Ht SDSCA)
25 weeks
IGF-1
25 weeks
IGFBP3
25 weeks
Interventions
0.1 mg/kg/wk once a week for 25 weeks
0.25 mg/kg/wk, once a day for 25 weeks
Eligibility Criteria
You may qualify if:
- have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration \<7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
- be in preadolescence (Tanner stage 1) and have a CA \>3 years;
- have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
- receive no prior GH treatment.
- sign informed consent
You may not qualify if:
- patients with severe cardiopulmonary
- patients with hematological diseases
- a current or past history of malignant tumors
- immunodeficiency diseases
- mental diseases
- patients positive for hepatitis B e-antibody (HBeAb)
- hepatitis B surface antigen (HBsAg)
- hepatitis B e antigen (HBeAg)
- patients with other growth disorders, such as Turner syndrome
- constitutional delay of growth and puberty, and Laron syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Huazhong University of Science and Technologycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Capital Medical Universitycollaborator
- Children's Hospital of Fudan Universitycollaborator
Related Publications (1)
Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.
PMID: 28566441RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoping Luo, Doctor
Tongji Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 27, 2011
Study Start
May 1, 2006
Primary Completion
January 1, 2007
Study Completion
February 1, 2007
Last Updated
July 31, 2017
Record last verified: 2011-05