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

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Brief Title

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

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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

pharmacokinetics parameter

Secondary Outcome

 IGF-1, IGFBP-3

Condition

Growth Hormone Deficiency

Intervention

somatropin AQ


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

March 2010

Completion Date

November 2010

Primary Completion Date

October 2010

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
      

Gender

Male

Ages

4 Years - 10 Years

Accepts Healthy Volunteers

No

Contacts

Luo Xiaoping, Doctor, , 



Administrative Informations


NCT ID

NCT01613573

Organization ID

GenSci-004 Clinical Trial


Responsible Party

Sponsor

Study Sponsor

GeneScience Pharmaceuticals Co., Ltd.

Collaborators

 Huazhong University of Science and Technology

Study Sponsor

Luo Xiaoping, Doctor, Principal Investigator, Tongji Hospital


Verification Date

October 2010