NCT04513171View on ClinicalTrials.gov

Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

434

Participants

Timeline

Start Date

December 26, 2018

Primary Completion Date

June 7, 2023

Study Completion Date

July 10, 2023

Conditions
Growth Hormone Deficiency
Interventions
DRUG

Y-shape pegylated somatropin

Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.

DRUG

Y-shape pegylated somatropin

Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.

DRUG

Y-shape pegylated somatropin

Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.

DRUG

Norditropin®

Norditropin 245μg/kg/week, subcutaneous injection, Once daily.

DRUG

Y-shape pegylated somatropin

Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.

DRUG

Norditropin

Norditropin 245μg/kg/week, subcutaneous injection, Once daily.

Trial Locations (1)

Unknown

Tongji Hospital, Tongji Medical College of HUST, Wuhan

All Listed Sponsors
collaborator

Tongji Hospital

OTHER

lead

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

NCT04513171 - Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children | Biotech Hunter | Biotech Hunter