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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375620
Recruitment Status : Unknown
Verified January 2015 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Collaborators:
Shanxi Provincial Maternity and Children's Hospital
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of Jilin University
Hunan Children's Hospital
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Small for Gestational Age Infant Biological: PEG-somatropin Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG-somatropin: Low dose
0.1 mg/(kg.w), once per week for 52 weeks.
Biological: PEG-somatropin
Experimental: PEG-somatropin: High dose
0.2 mg/(kg.w), once per week for 52 weeks.
Biological: PEG-somatropin



Primary Outcome Measures :
  1. 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. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Height [ Time Frame: 52 weeks ]
  2. Bone maturity (bone age change / actual age change: △BA/△CA) [ Time Frame: 52 weeks ]
  3. The mole ratio of IGF-1/IGFBP-3: ([IGF-1(ng/ml)/7.6]/[IGFBP-3 (ng/ml)/25.75]) [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375620


Contacts
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Contact: Xiaohua Feng 13610794989 fengxiaohua@gensci-china.com

Locations
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China, Hubei
Tongji Hospital of Tongji Medical College of HUST Recruiting
Wuhan, Hubei, China
Contact: Xiaoping Luo, Ph.D\         
China, Hunan
Hunan Children's Hospital Recruiting
Changsha, Hunan, China
Contact: Yan Zhong         
China, Jiangsu
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China
Contact: Zhuangjian Xu         
China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: Hongwei Du         
China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Feihong Luo         
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Xueyuan Gu         
China, Shanxi
Shanxi Provincial Maternity and Children's Hospital Recruiting
Taiyuan, Shanxi, China
Contact: Wenhui Song         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Shanxi Provincial Maternity and Children's Hospital
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of Jilin University
Hunan Children's Hospital
Investigators
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Principal Investigator: Xiaoping Luo, Ph.D Tongji Hospital of Tongji Medical College of HUST

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02375620     History of Changes
Other Study ID Numbers: GenSci 031 CT
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: January 2015