NCT06347588Active, not recruiting
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 26 Mar 2024
- Start date
- 6 Jun 2022
- Primary completion date
- May 2026
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Hepatitis B
- NCT number
- NCT06347588
What you commit to
- Study type: Observational
- Planned participants: 60
- From 6 Jun 2022 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients under prophylaxis for HBV
- Patients vaccinated for hepatitis B
- 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)
Other
- Patients who did not give informed consent
- Patients with HBsAg positivity
- Patients with hepatocellular carcinoma (HCC)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irccs San Matteo Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.