A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

GHD Clinical Trial

— ESCALATE  

Official title:

The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024967
• Other study ID #: GenSci004-302
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: Duan Peng
• Phone: +86-431-85195060
• Email: info[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Description:

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

Inclusion Criteria:

1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy

2. Participant must be 6 months to 17 years old

3. Tanner stage <5 at Visit 1

4. Open epiphyses

5. Normal fundoscopy at Screening

6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

Exclusion Criteria:

1. History or presence of malignant disease

2. Children with diabetes mellitus

3. Major medical conditions and/or presence of contraindications to GH treatment

4. Pregnancy

5. Participation in any other study of an investigational agent within three months prior to Visit 1

6. Prior exposure to investigational drug or any other long-acting growth hormone

7. Any other reason per investigator's discretion

Related Conditions & MeSH terms

• GHD

Intervention

Drug:
• PEG-somatropin
PEG-somatropin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events of once-weekly GenSci004 in children with GHD	Incidents of adverse events	108 weeks
Secondary	Annualized Height Velocity (AHV)	Measured in centimeter per year (cm/year)	104 weeks