Clinical Research Directory

Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)

Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser. The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).

A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers

The goal of this clinical trial is to assess the pharmacokinetic similarity of Biofilgragen, a filgrastim biosimilar, compared with EU-authorized Neupogen after single subcutaneous doses in healthy adult volunteers. The main questions it aims to answer are: * Are the maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time zero to infinity (AUC0-∞) of filgrastim similar between Biofilgragen and EU-authorized Neupogen? * What is the time to reach maximum observed serum concentration (tmax) and terminal elimination half-life (t½) following administration of each product? Researchers will compare Biofilgragen and EU-authorized Neupogen to assess pharmacokinetic similarity. Participants will: * Receive a single 5 μg/kg subcutaneous dose of Biofilgragen and a single 5 μg/kg subcutaneous dose of EU-Neupogen in a randomized sequence during two treatment periods. * Receive each study product after an overnight fast, with the two treatment periods separated by a minimum 32-day washout period. * Provide blood samples at predefined time points after each dose to measure serum filgrastim concentrations and determine pharmacokinetic parameters. * Undergo safety assessments and monitoring throughout the study, including the follow-up period.

the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer

This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2- breast cancer patients receiving ribociclib combined with endocrine therapy. The study plans to enroll 97 patients using a Simon two-stage design, with the primary endpoint being the incidence of severe neutropenia within 4 treatment cycles (4 months) after initiation. Secondary endpoints include the incidence of all-grade neutropenia, febrile neutropenia, ribociclib treatment intensity, and safety. The study will systematically assess the preventive efficacy and safety of leucogen to provide a basis for subsequent Phase III randomized controlled trials.

Prevalence of Ethnic Neutropenia and Duffy Null Phenotype in Neonates

This is a prospective observational study designed to assess the prevalence of the Duffy null phenotype (associated with ethnic neutropenia) in neonates born at Kaplan Medical Center. Blood samples will be collected from umbilical cords (non-invasively) to evaluate Duffy antigen expression. Data on ethnicity, perinatal factors, and routine blood counts at 9-12 months (when available) will also be collected to correlate phenotype with absolute neutrophil count (ANC).