Hepatitis B Research Network Adult Cohort Study
a study on Hepatitis B
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)
- 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.
Hepatitis B HBV Cohort Study Hepatitis A Hepatitis
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).
- 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
- University of California San Francisco
accepting new patients
San Francisco California 94143 United States
- California Pacific Medical Center
accepting new patients
San Francisco California 94115 United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01263587.