Growth Hormone Deficiency Clinical Trial
— PDOfficial title:
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
Verified date | May 2011 |
Source | GeneScience Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | February 2007 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GeneScience Pharmaceuticals Co., Ltd. | Capital Medical University, Children's Hospital of Fudan University, First Affiliated Hospital, Sun Yat-Sen University, Huazhong University of Science and Technology |
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth velocity | 25 weeks | ||
Secondary | height standard deviation score for chronological age (Ht SDSCA) | 25 weeks | ||
Secondary | IGF-1 | 25 weeks | ||
Secondary | IGFBP3 | 25 weeks |
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