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RECRUITING
NCT06857292
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

14 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

97

Start Date

2024-12-01

Completion Date

2025-12

Last Updated

2025-03-04

Healthy Volunteers

No

Interventions

DRUG

Telpegfilgrastim

Experimental group: Patients were subcutaneously injected with Telpegfilgrastim 33μg/kg (maximum dose ≤2mg) 24h after chemotherapy, 21 days for one chemotherapy cycle, and only one chemotherapy cycle was observed. Pharmacokinetic determination: Among them, 8 patients underwent pharmacokinetic determination. The pharmacokinetic sampling time points were blood samples taken before administration, 12 h, 24 h, 48 h, 120h, 168 h, 336 h, 480h after administration. A total of 8 blood samples were collected, and the pharmacokinetic characteristics of the experimental drugs were analyzed by ELISA.

Locations (1)

SunYat-senU

Guangzhou, Guangdong, China