Status:
UNKNOWN
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
GHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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.
Detailed 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.
Eligibility Criteria
Inclusion
- Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
- Participant must be 6 months to 17 years old
- Tanner stage \<5 at Visit 1
- Open epiphyses
- Normal fundoscopy at Screening
- Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant
Exclusion
- History or presence of malignant disease
- Children with diabetes mellitus
- Major medical conditions and/or presence of contraindications to GH treatment
- Pregnancy
- Participation in any other study of an investigational agent within three months prior to Visit 1
- Prior exposure to investigational drug or any other long-acting growth hormone
- Any other reason per investigator's discretion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06024967
Start Date
December 1 2023
End Date
September 1 2025
Last Update
September 11 2023
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