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

NCT01613573 | Completed Phase 1 DMC

• 1 other identifier: GenSci-004 Clinical Trial
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

pegylated Somatropin; PEG-GH; Phase 1 study; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• pharmacokinetics parameter

  Cmax, AUC during the time interval for the first dose and last dose, Half-Life(t1/2), Apparent body clearance(CL), Mean residence time(MRT),steady-state volume of distribution(Vss)

  Somatropin AQ: predose(0),1,2,3,4,6,8,10,12,16,20,24 hours post-dose. PEG somatropin: predose (0),2,4,8,12,18,24,36,48,72,96,120,144,168 hours post-dose

Secondary Outcomes (1)

• IGF-1, IGFBP-3

  Day I to Day 7 in each treatment period (33 time points) for daily used somatropin, Day I to Day 42 in each treatment period (35 time points) for PEG somatropin

Interventions

somatropin AQ DRUG

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

Also known as: Somatropin injection, rhGH

pegylated somatropin DRUG

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

Also known as: PEG somatropin, PEG GH, pharmacokinetics, growth hormone deficiency

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Huazhong University of Science and Technology: collaborator

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone; Pharmacokinetics

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Luo Xiaoping, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 7, 2012
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 14, 2012

Record last verified: 2010-10