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NOT YET RECRUITING
NCT07126288
PHASE2/PHASE3

Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

Key Details

Gender

All

Age Range

3 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

268

Start Date

2025-08-31

Completion Date

2028-12-23

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Norditropin NordiFlex

Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)

Locations (16)

Xiamen Maternal and Child Health Hospital

Xiamen, Fujian, China

Nanyang Central Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Suzhou University Children's Hospital

Suzhou, Jiangsu, China

Jiangxi Children's Hospital

Nanchang, Jiangxi, China

Pingxiang Maternal and Child Health Hospital

Pingxiang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Linyi Maternal and Child Health Hospital

Linyi, Shandong, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Meishan People's Hospital

Meishan, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Ningbo Women's and Children's Hospital

Ningbo, Zhejiang, China