NCT04547829

Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy：A Multi-center, Single Arm Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

Detailed description

The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Conditions

• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	pegylated recombinant human granulocyte-colony stimulating factor	The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-10-10
• Completion: 2023-05-10
• First posted: 2020-09-14
• Last updated: 2021-09-02

Locations

1 site across 1 country: China