Clinical trial • Phase IV • Haematology|Immunology

pegfilgrastim for Severe chronic neutropenia

Phase IV trial of pegfilgrastim for Severe chronic neutropenia. 20 participants.

Overview

Phase IV trial across 1 site in Italy.

Recruits 20 paediatric patients.

Pregnancy Exclusion: Pregnancy and nursing woman
Vulnerable Population: Vulnerable population selected. Trial includes participants of multiple age ranges and there are subject information and informed consent documents for parents/guardian, adults and child (documents titled 'L1_SIS and ICF parents-guardian', 'L1_SIS and ICF adults', 'L1_SIS and ICF child'), indicating that consent for minors is obtained from parents/guardians and a child information/assent form is provided.

{"criterion_text":"-Patients, none age limits, affected with either congenital or acquired chronic neutropenia defined as absolute neutrophil count < 500/mmc (based on three consecutive tests at least one week apart within a minimum three-months period) already being treated with G-CSF (daily)."}

{"criterion_text":"-Subjects affected with autoimmune neutropenias or idiopathic neutropenia that are not being treated/occasionally treated with growth factor\n-Subjects affected with iatrogenic neutropenia anticancer drug-induced\n-Subject affected with neutropenia induced by myelodysplastic syndrome and or leukemia with/without clonal cytogenetic abnormalities\n-Subject affected with acquired or congenital neutropenia diagnosis\n-Subjects affected with hepatic or renal impairment\n-Subjects affected with homozygous sickle cell disease or subjects affected with double heterozygosity inheritance of HbS and β-thalassemia\n-Pregnancy and nursing woman"}

{"endpoint_text":"-Median of absolute neutrophil count (from second to six months-period of study)","definition_or_measurement_approach":"Median absolute neutrophil count measured between month 2 and month 6 of the study (specified as 'from second to six months-period of study')."}

{"endpoint_text":"-Number, type and duration of the infections (from second to six months-period of study)","definition_or_measurement_approach":"Number, classification (type) and duration of infections assessed between month 2 and month 6 of the study."}
{"endpoint_text":"-Number of antibiotic courses (from second to six months-period of study)","definition_or_measurement_approach":"Count of antibiotic treatment courses administered between month 2 and month 6 of the study."}
{"endpoint_text":"-Numbero of hospitalizations (from second to six months-period of study)","definition_or_measurement_approach":"Count of hospitalizations occurring between month 2 and month 6 of the study."}

Planned Sample Size: 20
Recruitment Window Months: 300
Consent Approach: Informed consent forms are provided. Separate subject information and informed consent forms are listed for parents/guardians, adults and children (documents: 'L1_SIS and ICF parents-guardian', 'L1_SIS and ICF adults', 'L1_SIS and ICF child'), indicating that adults provide their own consent and minors provide assent with parents/guardians giving consent. Languages of the documents are not specified in the available data.

Investigational Product Name: Neulasta 6 mg solution for injection
Active Substance: pegfilgrastim
Modality: Peptide/protein/enzyme
Routes Of Administration: Subcutaneous
Route: Subcutaneous
Authorisation Status: Authorised (EU marketing authorisation EU/1/02/227/004)
Starting Dose: 6 mg
Maximum Dose: 324 mg/Kg

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