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

NCT02314676 | Unknown Phase 4

• 1 other identifier: GenSci 004 CT
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad population of children. Half of participants will receive the high dose, while the other half will receive the low dose.

Conditions

Dwarfism, Pituitary

Outcome Measures

Primary Outcomes (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

  26 weeks

Study Arms (1)

PEG-somatropin

EXPERIMENTAL

Biological: PEG-somatropin

Interventions

PEG-somatropin BIOLOGICAL

PEG-somatropin

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 B e 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.
• Potential tumor patients (family history).
• Diabetic.
• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (2)

First People's Hospital of Wuhu

Wuhu, Anhui, China

RECRUITING

Children's Hospital Affiliated to Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Junfen Fu, Ph.D

  Children's Hospital Affiliated to Medical College of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfen Fu, Ph.D

CONTACT

13777457849; fjf68@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 11, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

CN (2)