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Clinical Trials in Italy / NCT06347588
Active, not recruiting Observational

Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.

NCT06347588 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2022-06-06
Last updated
2025-12-24

Condition(s) studied

Occult Hepatitis B Infection in Cancer Patients

Investigational drug(s) / intervention(s)

Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA

Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA: Blood sample at baseline, week 4, month 3, 6, 9,12.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Life-expectancy (as estimated by treating physician) ≥ 6 months; * Patients HBsAg negative * Patients HBcAb positive with or without HBV-DNA detectable * Patients with cancer undergoing immunotherapy with or without chemotherapy Exclusion Criteria: * Patients who did not give informed consent * Patients under prophylaxis for HBV * Patients vaccinated for hepatitis B * Patients with HBsAg positivity * Patients with HIV positivity * Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use * Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease) * Patients with current active Hepatitis C virus (HCV-positive) * Patients with hepatocellular carcinoma (HCC)

Primary outcome measure(s)

  • To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV — 3 weeks after first cycle of therapy and every 3 months until the end of the study
    Occult hepatitis B (OBI) detectable in serum HBV DNA, negative antigen test surface hepatitis B (HBsAg) and with positivity to anti-HBc (OBI seropositive). pOBI: Based on the intermittent detection of HBV DNA, we define pOBI (OBI potential) patients with negative HBV-DNA and positivity to anti-HBc.

Trial sites (1)

FacilityCityRegionStatus
Irccs San Matteo Pavia Pavia PV

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06347588 on ClinicalTrials.gov ↗ ← All trials in Italy