GHD
Conditions
Keywords
GHD, growth hormone deficiency
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.
Interventions
DRUGPEG-somatropin
PEG-somatropin
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of once-weekly GenSci004 in children with GHD | 108 weeks | Incidents of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Height Velocity (AHV) | 104 weeks | Measured in centimeter per year (cm/year) |
Contacts
Primary ContactDuan Peng
Outcome results
None listed