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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Capital Medical University; Children's Hospital of Fudan University; First Affiliated Hospital, Sun Yat-Sen University; Huazhong University of Science and Technology
• Treatments: Hormones

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.

• 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