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

PHASE2RecruitingINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Chemotherapy-Induced Neutropenia
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."

Trial Locations (1)

510060

RECRUITING

SunYat-senU, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER