Rapid T-cell analysis for patients with chronic HBV and HBV/HDV disease
Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBV/HDV Disease
This study looks at how the immune system responds over time in people with chronic HBV and HBV/HDV infections to see how well treatments work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06372990 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the immune response in patients with chronic HBV infection and HBV-HDV co-infection over time. It will collect data on the natural history of the infection and the effects of antiviral therapies. The study is conducted at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy, in collaboration with Duke-NUS Medical School in Singapore. Participants will be monitored for their immune response and disease outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic HBV infection or HBV-HDV co-infection.
Not a fit: Patients with co-infections from other hepatotropic viruses or those on immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses in chronic HBV and HBV/HDV infections, potentially leading to improved treatment strategies.
How similar studies have performed: While similar studies have explored immune responses in viral infections, this specific approach focusing on chronic HBV and HBV/HDV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * ability to understand and sign the informed consent * chronic HBV infection or HBV-HDV co-infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months Exclusion Criteria: * Co-infection with other hepatotropic viruses (HCV, HIV) * Treatment with immunosuppressive/immunomodulatory drugs * Other congenital and/or acquired immunodeficiency conditions
Where this trial is running
Milan, MI
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. — Milan, Mi, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.