D-SOLVE Study of Hepatitis D Virus Infection Cohorts A and B Observational Study to Understand Patient Factors and Treatment Responses

What this Trial Is About

Hepatitis D is the most severe form of chronic viral hepatitis, often leading to liver failure, liver cancer, and death. It occurs due to co-infection with hepatitis B virus and hepatitis D virus. Researchers are studying a large group of well-defined HDV-infected patients to better understand how individual factors affect the course of the disease and to identify which patients might benefit from current treatments. This observational study is part of the D-SOLVE consortium funded by the European Union to develop personalized management approaches for hepatitis D. The study includes two cohorts. Cohort A involves 750 HDV-infected patients, both treated and untreated, from multiple centers in Europe, examining their demographic, clinical, virological, and immunological characteristics. Cohort B includes HDV patients with past or current liver biopsies and clinical follow-up to study features linked to liver fibrosis progression and complications. Biological samples and clinical data will be collected retrospectively and prospectively for biomarker analysis and mechanistic studies. Participants will provide clinical and virological information, along with biological material for detailed biomarker screening over three years. Researchers will analyze demographic and disease features related to severity and treatment response. The main outcome is biosample screening conducted over three years. This study aims to improve patient monitoring and treatment strategies to reduce disease burden and improve quality of life for people with hepatitis D.

D-SOLVE Cohorts (Cohort a and B)