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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Hepatitis B HBV Cohort Study

Eligibility

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.

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

Locations

  • California Pacific Medical Center accepting new patients
    San Francisco, California, 94115, USA
  • Cedars Sinai Medical Center terminated
    Los Angeles, California, 90048, USA
  • University of California Los Angeles terminated
    Los Angeles, California, 90095, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pittsburgh
Links
The Hepatitis B Research Network study web site
ID
NCT01263587
Lead Scientist
Norah Terrault
Study Type
Observational
Last Updated
May 2016
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