A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called GenSci004, which is a growth hormone that is given once a week. The study aims to find out if this treatment is safe and effective for children who have Growth Hormone Deficiency (GHD), a condition where the body doesn't produce enough growth hormone. The trial will involve children aged 6 months to 17 years, and it will last for about 108 weeks, or just over two years.

To participate, children need to have been diagnosed with GHD and be in a certain stage of growth development. They should not have any serious health issues, like cancer or diabetes, and must have their parents’ or guardians' consent. During the study, participants will receive the treatment and be monitored by doctors to see how well it works and if there are any side effects. This trial is not yet recruiting participants, but it aims to help improve treatment options for children with GHD in the future.

Gender

ALL

Eligibility criteria

• 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