Trials / Active Not Recruiting
Active Not RecruitingNCT06347588
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.
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA | Blood sample at baseline, week 4, month 3, 6, 9,12. |
Timeline
- Start date
- 2022-06-06
- Primary completion
- 2026-05-01
- Completion
- 2026-12-01
- First posted
- 2024-04-04
- Last updated
- 2025-12-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06347588. Inclusion in this directory is not an endorsement.