Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
Condition(s) studied
Investigational drug(s) / intervention(s)
GB08: In Phase II trial, eligible PGHD patients will receive GB08 0.4mg/kg, 0.8mg/kg, or 1.2mg/kg subcutaneous injection, once a week for 24 weeks. In Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II.
Norditropin NordiFlex: Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)
Study summary
This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD). It seeks to resolve the following questions:
* 1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?
* 2: Which dose (0.4 mg/kg, 0.8 mg/kg, and 1.2 mg/kg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?
* 3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.
This is a Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial with two stages. Stage 1 answers questions #1 and #2 by comparing the efficacy and safety of GB08 injection and Norditropin NordiFlex intervention among PGHD at 24 weeks. It involves four groups (n=16 each): GB08 0.4 mg/kg, GB08 0.8 mg/kg, GB08 1.2 mg/kg, and Norditropin NordiFlex 0.035 mg/kg. GB08 and Norditropin NordiFlex will be administered once weekly and once daily, respectively. The primary outcome measurement is annualized height velocity (AHV) at 24 weeks. Other measurements include growth hormone levels, safety parameters, immunogenicity markers, and pharmacokinetic/pharmacodynamic profiles.
The optimal GB08 dose will be further investigated in Stage 2, which answers question #3. At this stage, PGHD patients will randomly receive either GB08 injection or Norditropin NordiFlex intervention for 52 weeks (n=102 for each). After that, the efficacy and safety of GB08 will also be detected.
Eligibility
Primary outcome measure(s)
- PhaseII-Comparison of annualized height velocity at 24 weeks — From enrollment to end of treatment at 24 weeks
Comparison of annualized height velocity of PGHD patients receiving 24-week GB08 and Norditropin NordiFlex treatment - PhaseIII-Comparison of annualized height velocity at week 52 — From enrollment to end of treatment at week 52
Comparison of annualized height velocity between PGHD patients receiving GB08 and Norditropin NordiFlex at 52 weeks
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Xiamen Maternal and Child Health Hospital | Xiamen | Fujian | |
| Nanyang Central Hospital | Nanyang | Henan | |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | |
| The Third Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | |
| Wuhan Children's Hospital | Wuhan | Hubei | |
| Suzhou University Children's Hospital | Suzhou | Jiangsu | |
| Jiangxi Children's Hospital | Nanchang | Jiangxi | |
| Pingxiang Maternal and Child Health Hospital | Pingxiang | Jiangxi | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| Linyi Maternal and Child Health Hospital | Linyi | Shandong | |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | |
| Meishan People's Hospital | Meishan | Sichuan | |
| The Second People's Hospital of Yibin | Yibin | Sichuan | |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | |
| Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Ningbo Women's and Children's Hospital | Ningbo | Zhejiang |
More Shenzhen Kexing Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07126288 on ClinicalTrials.gov ↗ ← All trials in China