Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT03290235
• Date of registration: 19/09/2017
• Prospective Registration: No
• Primary sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Public title: Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
• Scientific title: The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
• Date of first enrolment: March 1, 2017
• Target sample size: 1500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03290235
• Study type: Interventional
• Study design: Allocation: Non-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:

- Children has completed all visits and therapy in previous phase IV study;

- Investigators evaluate subjects could continue growth hormone therapy;

- Subjects is willing and able to cooperate to complete scheduled visits, treatment
plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

- Children with epiphyseal closure;

- Children is near the adule final height, that is, growth rate= 2 cm / year or bone age
= 14 years old for girls, bone age = 16 years old for boys;

- Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper
limit of normal);

- Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other
components of the study product;

- Patients with severe cardiopulmonary or hematological diseases, a current or past
history of malignant tumors, immunodeficiency diseases, or mental diseases;

- Patients with diabetics;

- Patients with congenital bone dysplasia or scoliosis;

- Patients took drugs that would influence the efficacy and safety of PEG-Somatropin
after phase IV study and before screening for this extension study;

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



Age minimum: 42 Months
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Retardation

Intervention(s)

Drug: PEG-somatropin

Primary Outcome(s)

Ht SDSca (Height standard deviation score for chronological age) [Time Frame: Baseline, every 13 weeks until 130 weeks]

Secondary Outcome(s)

Ht SDSBA (Height standard deviation score for bone age) [Time Frame: Baseline, every 13 weeks until 130 weeks]

IGF-1 SDS (Standard deviation score of insulin-like growth factor-1) [Time Frame: Baseline, every 13 weeks until 130 weeks]

Yearly growth velocity [Time Frame: Baseline, every 13 weeks until 130 weeks]

Bone age [Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks]

Near final height for some subjects [Time Frame: Baseline, every 13 weeks until 130 weeks]

Secondary ID(s)

GenSci 045 CT-Extension Period

Source(s) of Monetary Support

Please refer to primary and secondary sponsors