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

NCT06857292 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-03-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857292 on ClinicalTrials.gov