Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342146

Acronym

Enrollment

101

Registered

2011-04-27

Start date

2006-05-31

Completion date

2007-02-28

Last updated

2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Keywords

pegylated Somatropin, PEG-GH, Growth hormone, PEG-rhGH, Growth hormone deficiency (GHD), Phase 2 study

Brief summary

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Interventions

DRUGpegylated Somatropin

0.1 mg/kg/wk once a week for 25 weeks

DRUGJintropin AQ

0.25 mg/kg/wk, once a day for 25 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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. * sign informed consent

Exclusion criteria

* patients with severe cardiopulmonary * patients with hematological diseases * a current or past history of malignant tumors * immunodeficiency diseases * mental diseases * patients positive for hepatitis B e-antibody (HBeAb) * hepatitis B surface antigen (HBsAg) * hepatitis B e antigen (HBeAg) * patients with other growth disorders, such as Turner syndrome * constitutional delay of growth and puberty, and Laron syndrome

Design outcomes

Primary

Measure	Time frame
Growth velocity	25 weeks

Secondary

Measure	Time frame
height standard deviation score for chronological age (Ht SDSCA)	25 weeks
IGF-1	25 weeks
IGFBP3	25 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026