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

NCT01495468 | Completed Phase 3 DMC

• 1 other identifier: GenSci-004-CT
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 6

Brief Summary

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

Conditions

Growth Hormone Deficiency

Keywords

pegylated somatropin; PEG-rhGH; growth hormone; Growth Hormone Deficiency; phase III study

Outcome Measures

Primary Outcomes (1)

• yearly growth velocity

  growth velocity add as GV was the primary outcome measure

  6 months

Secondary Outcomes (4)

• Ht SDSca

  6 months

• IGF-l

  6 months

• IGFBP-3

  6 months

• bone maturity

  6 months

Interventions

PEG-somatropin BIOLOGICAL

drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months

Also known as: recombinant human growth hormone, peglyated growth hormone, PEG-GH

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration \<7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
• be in preadolescence (Tanner stage 1) and have a CA \> 3 years
• have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
• receive no prior GH treatment.
• sign informed consent

You may not qualify if:

• \. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
• Known hypersensitivity to Somatropin or any other components of the study product.
• \. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
• \. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
• \. Subjects took part in other clinical trial study during 3 months.
• \. Other conditions which in the opinion of the investigator preclude enrollment into the study.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Tongji Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Capital Medical University: collaborator
• Children's Hospital of Fudan University: collaborator
• The First Hospital of Jilin University: collaborator

Study Sites (6)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changchun, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Wuhan, China

Location

Related Publications (1)

• Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.

  PMID: 28566441 RESULT

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Xiaoping Luo, Ph. D

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 31, 2017

Record last verified: 2011-12

Locations

CN (6)