Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Aims - Primary Aim: o To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression - Secondary Aims: - To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada - To evaluate changes in HBV infection status and quantitative hepatitis B surface antigen (HBsAg) levels and factors associated with those changes - To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal Alanine transaminase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months - To develop a bank of biospecimens (e.g., serum, plasma, DNA, lymphocytes, liver tissue) obtained from participants with HBV infection - To identify participants with HBV infection who are potential candidates in one of the treatment studies to be conducted by the Hepatitis B Research Network (HBRN) - To describe the natural history of hepatitis B infection in pregnancy including the frequency of, and clinical and virological characteristics associated with, hepatic flares during pregnancy and post-partum.

Who is eligible to participate?

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers. Inclusion criteria - Written informed consent - At least 18 years of age - Hepatitis B surface antigen (HBsAg) positive and either: - Pregnant - Anti-Hepatitis D positive - Diagnosed with acute Hepatitis B 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 (NCT01298037). Exclusion Criteria: - Hepatic decompensation - Hepatocellular carcinoma (HCC) - Liver transplantation - Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive) - Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV) or Hepatitis C (HCV) co-infection are not excluded). - Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol - Unable or unwilling to return for follow-up visits

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