GHD Clinical Trial
— ESCALATEOfficial 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Changchun GeneScience Pharmaceutical Co., Ltd. |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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