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.
Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)
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
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.
Hepatitis BHBVCohort Study
For people ages 18 years and up
The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.
Written informed consent
At least 18 years of age
Hepatitis B surface antigen (HBsAg) positive and either:
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).
Hepatocellular carcinoma (HCC)
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
University of California San Franciscoaccepting new patients San Francisco, California, 94143, United States
California Pacific Medical Centeraccepting new patients San Francisco, California, 94115, United States
Cedars Sinai Medical Centerterminated Los Angeles, California, 90048, United States
University of California Los Angelesterminated Los Angeles, California, 90095, United States