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Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Summary
The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.
Official title: Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2022-06-06
Completion Date
2026-12
Last Updated
2025-12-24
Healthy Volunteers
No
Interventions
Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA
Blood sample at baseline, week 4, month 3, 6, 9,12.
Locations (1)
Irccs San Matteo Pavia
Pavia, PV, Italy