Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02380235
• Date of registration: 02/03/2015
• Prospective Registration: No
• Primary sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Public title: Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
• Date of first enrolment: December 2014
• Target sample size: 600
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02380235
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Xiaohua Feng

Key inclusion & exclusion criteria

Inclusion Criteria:

- Before starting treatment, according to the medical history, clinical symptoms and
signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

- According to the height statistical data of Chinese children's physique
development in nine cities in 2005,height is lower than the third percentile of
growth curve of normal children with the same age and gender.

- Height velocity (HV) =5.0 cm/yr.

- GH stimulation test with two different mechanisms affirms that GH peak
concentration of patients' plasma<10.0ng/ml.

- Bone age (BA) =9 years in girls and =10 years in boys, at least 1 year less than
his/her chronological age (CA).

- Be in preadolescence (Tanner stage 1) and have a CA ? 3 years.

- Receive no prior GH treatment within 6 months.

- Sign informed consent.

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 positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
(HBsAg) or hepatitis Be antigen (HBeAg).

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

- People with severe cardiopulmonary, hematological and malignant tumors diseases or
general infection and immune deficiency.

- Diabetic.

- Potential tumor patients (family history).

- Abnormal growth and development, such as Turner syndrome, constitutional delay of
growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth
retardation without excluding abnormal chromosome.

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

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



Age minimum: 3 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Biological: PEG-somatropin

Primary Outcome(s)

Ht SDSca [Time Frame: Baseline, 4,12,26 weeks after initiating treatment]

Secondary ID(s)

GenSci 004 CT-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors