Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature

Small for Gestational Age Infant Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375620
• Other study ID #: GenSci 031 CT
• Status: Recruiting
• Phase: Phase 2
• First received: February 1, 2015
• Last updated: February 24, 2015
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2015
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 13610794989
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.

Description:

This was a multicenter, randomized phase II study, half of participants will receive the high dose, while the other half will receive the low dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• The patients are diagnosed as being clinically full term small for gestational age infant.

• Girl are 3-6 years old, boys are 3-7 years old.

• Be in preadolescence (Tanner stage 1).

• The child did not achieve catch-up growth when he/she entered the group (the definition of catch-up growth is that the height is higher the third percentile with the same age and gender) (Appendix 2 and 3).

• The height of child is shorter than -2SDS of the median of normal children with the same age and gender when he/she entered the group (the mean height and height standard deviation of normal children with the same age and gender of normal children regard the height data in the physical development investigation data of children aged 0-18 in 9 cities of China (2005) as standard [13], Appendix 4 and 5).

• Within a year before entering the group, after any growth hormone stimulation test, the peak concentration of growth hormone in serum>10 µg/L.

• Bone age= the actual age+1.

• The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.

• Birth gestational age = 37 weeks.

• The subjects and their guardians sign the informed consent (if the subjects is lack of ability for signing the informed consent, his legal guardian can write the subjects name instead).

Exclusion Criteria:

• People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).

• Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).

• People with known highly allergic constitution or allergy to the drug or the excipient of the study.

• People with diabetes, severe cardiopulmonary, hematological system and malignant tumors diseases or general infection, immune deficiency and patients with mental disease.

• Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency.

• Potential tumor patients (family history).

• Patients who used growth hormone for treatment.

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

• Patients used other hormonal for treatment within 3 months (such as sex hormone, glucocorticoid and etc., treat for more than a month) and received the drug treatment which may interfere with the secretion of GH or GH function (oxandrolone, growth hormone releasing hormone and etc.);

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Small for Gestational Age Infant

Intervention

Biological:
• PEG-somatropin

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin
China	Hunan Children's Hospital	Changsha	Hunan
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanxi Provincial Maternity and Children's Hospital	Taiyuan	Shanxi
China	Tongji Hospital of Tongji Medical College of HUST	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (6)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Children's Hospital of Fudan University, First Hospital of Jilin University, Hunan Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actual height of the patient after treatment compared with the mean height of the population and the standard deviation (SD) of the height of the population for that chronological age.		52 weeks	No
Secondary	Height		52 weeks	No
Secondary	Bone maturity (bone age change / actual age change: ?BA/?CA)		52 weeks	No
Secondary	The mole ratio of IGF-1/IGFBP-3: ([IGF-1(ng/ml)/7.6]/[IGFBP-3 (ng/ml)/25.75])		52 weeks	No