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

Growth Hormone Deficiency Clinical Trial

— PD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342146
• Other study ID #: GenSci-004 CT
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2011
• Last updated: July 27, 2017
• Start date: May 2006
• Est. completion date: February 2007

Study information

• Verified date: May 2011
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• pegylated Somatropin
0.1 mg/kg/wk once a week for 25 weeks
• pegylated Somatropin
0.2 mg/kg/wk once a week for 25 weeks
• Jintropin AQ
0.25 mg/kg/wk, once a day for 25 weeks

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Capital Medical University, Children's Hospital of Fudan University, First Affiliated Hospital, Sun Yat-Sen University, Huazhong University of Science and Technology

References & Publications (1)

Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth velocity		25 weeks
Secondary	height standard deviation score for chronological age (Ht SDSCA)		25 weeks
Secondary	IGF-1		25 weeks
Secondary	IGFBP3		25 weeks

External Links

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