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

NCT ID: NCT01613573

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

Brief Summary

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

somatropin AQ

somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period

Intervention Type: DRUG

pegylated somatropin

Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Somatropin injection; rhGH; PEG somatropin; PEG GH; pharmacokinetics; growth hormone deficiency

Eligibility Criteria

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 study
• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luo Xiaoping, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Other Identifiers

GenSci-004 Clinical Trial

Identifier Type: -

Identifier Source: org_study_id