Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

Growth Hormone Deficiency Clinical Trial

Official title:

Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495468
• Other study ID #: GenSci-004-CT
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2011
• Last updated: July 27, 2017
• Start date: March 2007
• Est. completion date: March 2008

Study information

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

Clinical Trial Summary

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).

All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.

Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV=4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) =9 years in girls and =10 years in boys, at least 2 year 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:

• 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)

• 2.Known hypersensitivity to Somatropin or any other components of the study product.

• 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases

• 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome

• 5. Subjects took part in other clinical trial study during 3 months.

• 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.

Related Conditions & MeSH terms

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

Intervention

Biological:
• PEG-somatropin
drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Country where clinical trial is conducted

China, 

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	yearly growth velocity	growth velocity add as GV was the primary outcome measure	6 months
Secondary	Ht SDSca	Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age	6 months
Secondary	IGF-l		6 months
Secondary	IGFBP-3		6 months
Secondary	bone maturity		6 months

External Links

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