NCT03245333

A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)

Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 24 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.

Conditions

• Small for Gestational Age Infant

Interventions

Type	Name	Description
DRUG	Recombinant Human Growth Hormone Injection	Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
DRUG	Recombinant Human Growth Hormone Injection	Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• First posted: 2017-08-10
• Last updated: 2017-12-12

Locations

5 sites across 1 country: China