Actively Recruiting
D-SOLVE Cohorts (Cohort A and B) for Hepatitis D Virus Infection and Chronic Liver Disease
Led by Hannover Medical School · Updated on 2025-03-12
750
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hannover Medical School
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
D-SOLVE Cohorts (Cohort a and B)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive test for anti-HDV antibodies
- Age 18 years or older
- Any gender (male, female, diverse)
- Able to provide informed consent for study procedures
You will not qualify if you...
- Negative test for anti-HDV antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who undergo routine care are observed to collect clinical and virological data, as well as biomaterial for biomarker analysis.
Visits as per routine clinical care and study assessments
Trial Site Locations
Total: 4 locations
1
Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology
Hanover, Germany, 30625
Actively Recruiting
2
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)
Milan, Italy
Not Yet Recruiting
3
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, Romania, 021105
Actively Recruiting
4
Karolinska University Hospital and Karolinska Institutet
Stockholm, Sweden
Actively Recruiting
Research Team
P
Petra Dörge
J
Julia Kahlhöfer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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