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

Phase 3

Completed

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT01495468
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-20
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
yearly growth velocity	6 months	growth velocity add as GV was the primary outcome measure

Secondary Outcome Measures

Name	Time	Method
IGFBP-3	6 months
Ht SDSca	6 months	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
IGF-l	6 months
bone maturity	6 months