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Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

NCT03701841 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2018-10-10

No results posted yet for this study

Summary

This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

DRUG

PEG-rhG-CSF

All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT03701841 on ClinicalTrials.gov