Hepatitis B Research Network Adult Cohort Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 10-003286
NCT ID: NCT01263587
Sponsor Protocol Number: 10-003286
About this study
The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Written informed consent.
- At least 18 years of age.
- HBsAg-positive and either:
- Pregnant;
- Anti-HDV positive;
- Diagnosed with acute HBV infection or experiencing a hepatitis flare;
- Immune tolerant or immune active phenotype;
- Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study;
- OR completed the HBRN Adult Immune Active trial (regardless of HBsAg status).
Exclusion Criteria:
- History of hepatic decompensation based on clinical or laboratory criteria.
- Hepatocellular carcinoma (HCC).
- History of solid organ transplantation or bone marrow transplantation.
- Current hepatitis B antiviral treatment (except pregnant women, and patients who are anti-HDV positive, and participants who completed the HBRN Adult Immune Active trial).
- Chronic immunosuppression therapy.
- Known HIV co-infection (patients with HDV or HCV co-infection are not excluded).
- Medical or social condition which, in the opinion of the investigator, would make the patient unsuitable for the study or interfere with or prevent follow up per protocol.
- Unable or unwilling to return for follow-up visits.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available