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

NCT04513171 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2024-01-24

No results posted yet for this study

Summary

This is a multicenter, randomized, open-labeled, positive controlled phase 2\&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.

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.

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo, MD, Ph.D · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2023-06-07
Completion
2023-07-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04513171 on ClinicalTrials.gov