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

NCT01613573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-06-14

No results posted yet for this study

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

Interventions

DRUG

somatropin AQ

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

DRUG

pegylated somatropin

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

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Luo Xiaoping, Doctor · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-10-31
Completion
2010-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613573 on ClinicalTrials.gov