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NCT Number: NCT01342146

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

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegylated somatropin

Drug

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

Other names: PEG-rhGH,PEG-growth hormone,PEG-Somatropin

Jintropin AQ

Drug

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

Other names: Somatropin injectable solution,rhGH injection

Primary outcomes

  1. Growth velocity

    Time frame: 25 weeks

Secondary outcomes

  1. height standard deviation score for chronological age (Ht SDSCA)

    Time frame: 25 weeks

  2. IGF-1

    Time frame: 25 weeks

  3. IGFBP3

    Time frame: 25 weeks

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Capital Medical University
  • Children's Hospital of Fudan University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Huazhong University of Science and Technology

Registry information

Official study title

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

Acronym: PD

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2011
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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