Characterizing immune and viral responses in chronic Hepatitis D patients treated with Bulevirtide
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment
This study is trying to see how well Bulevirtide treatment works for people with chronic Hepatitis D and how their immune system responds over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06504485 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the immunological and virological responses of patients with chronic Hepatitis D virus (HDV) infection who are being treated with Bulevirtide. It involves a collaboration between several institutions in Italy, focusing on understanding the immune response and disease progression in patients co-infected with Hepatitis B virus (HBV) and HDV. The study will analyze the role of CD4 and CD8 T cells in the context of chronic HDV infection, which is poorly understood. Participants will be monitored for their responses to the treatment over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic HDV infection confirmed by specific viral markers.
Not a fit: Patients co-infected with other viruses such as HCV or HIV, or those on immunosuppressive therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of chronic Hepatitis D infections, potentially enhancing treatment outcomes.
How similar studies have performed: While there is ongoing research in the field of Hepatitis D, this specific approach focusing on the immune response to Bulevirtide treatment 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 HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment. Exclusion Criteria: * Co-infection with other viruses (HCV, HIV) * Treatment with immunosuppressive/immunomodulatory drugs * Other congenital and/or acquired immunodeficiency conditions
Where this trial is running
Milan
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Pietro Lampertico, MD
- Email: pietro.lampertico@unimi.it
- Phone: 0255035432
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.