drugset / Trial / NCT06857292

Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy

NCT06857292

Phase 2 Recruiting 97 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelPrevention

Summary

This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.) undergoing chemotherapy, while also studying the pharmacokinetic characteristics of Telpegfilgrastim in children with cancer.

Timeline

Start
2024-12-01
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Telpegfilgrastim Protein / enzyme biologic 33 ug/kg Subcutaneous

Indications