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Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

Information source: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Deficiency

Intervention: somatropin AQ (Drug); pegylated somatropin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GeneScience Pharmaceuticals Co., Ltd.

Official(s) and/or principal investigator(s):
Luo Xiaoping, Doctor, Principal Investigator, Affiliation: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology


The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

Clinical Details

Official title: A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetics parameter

Secondary outcome: IGF-1, IGFBP-3


Minimum age: 4 Years. Maximum age: 10 Years. Gender(s): Male.


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 or stop the GH treatment for more than 4 weeks;sign informed consent Exclusion Criteria:

- Patients with Liver and kidney dysfunction (ALT> upper limit of normal 2 times, Cr>

upper limit of normal), hepatitis B virus detection, antigen-HBc, HBsAg and HBeAg are positive

- patients with known to a highly allergic constitution or allergic to the drug of this


- Patients with diabetes, serious cardiopulmonary, blood system, malignant tumor and

other diseases or systemic infection in immunocompromised and mental diseases

- Patients with other growth disorders, such as Turner syndrome, constitutional delay

of growth and puberty, Laron syndrome, GH receptor deficiency, girls with growth delay have not ruled out chromosomal abnormalities

- Participated in clinical trials of other drugs in 3 months

- Other cases that the researchers considered unsuitable for this clinical trial

Locations and Contacts

Additional Information

Starting date: March 2010
Last updated: June 13, 2012

Page last updated: August 23, 2015

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