Hepatitis B Research Network Adult Cohort Study

Overview

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.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20152033

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