Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2051 participants
OBSERVATIONAL
2010-12-31
2021-06-09
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Center for Research Resources (NCRR)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Anna Lok
Study Chair
Principal Investigators
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Steven Belle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
The Queen's Medial Center
Honolulu, Hawaii, United States
NIH Clinical Center
Bethesda, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Toronto Western Hospital Liver Centre
Toronto, Ontario, Canada
Countries
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References
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Lisker-Melman M, King WC, Ghany MG, Chung RT, Hinerman AS, Cloherty GA, Khalili M, Jain MK, Sulkowski M, Sterling RK. Human immunodeficiency virus coinfection differentially impacts hepatitis B virus viral markers based on hepatitis Be antigen status in patients with suppressed viremia. J Viral Hepat. 2023 Aug;30(8):700-709. doi: 10.1111/jvh.13857. Epub 2023 Jun 6.
Sterling RK, Wahed AS, Cloherty G, Hoofnagle JH, Lee WM; Hepatitis B Research Network Investigators. Acute Hepatitis B Virus Infection in North American Adults. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1881-1892.e4. doi: 10.1016/j.cgh.2022.09.004. Epub 2022 Sep 16.
Khalili M, Kleiner DE, King WC, Sterling RK, Ghany MG, Chung RT, Bhan AK, Rosenthal P, Lisker-Melman M, Ramachandran R, Lok AS; ; and the Hepatitis B Research Network (HBRN). Hepatic Steatosis and Steatohepatitis in a Large North American Cohort of Adults With Chronic Hepatitis B. Am J Gastroenterol. 2021 Aug 1;116(8):1686-1697. doi: 10.14309/ajg.0000000000001257.
Evon DM, Lin HS, Khalili M, Fontana RJ, Yim C, Wahed AS, Fried MW, Hoofnagle JH; Hepatitis B Research Network (HBRN). Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis. Aliment Pharmacol Ther. 2020 Feb;51(4):457-468. doi: 10.1111/apt.15618. Epub 2020 Jan 14.
Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2.
Khalili M, Shuhart MC, Lombardero M, Feld JJ, Kleiner DE, Chung RT, Terrault NA, Lisker-Melman M, Sanyal A, Lok AS; Hepatitis B Research Network (HBRN); Harvard Consortium. Relationship Between Metabolic Syndrome, Alanine Aminotransferase Levels, and Liver Disease Severity in a Multiethnic North American Cohort With Chronic Hepatitis B. Diabetes Care. 2018 Jun;41(6):1251-1259. doi: 10.2337/dc18-0040. Epub 2018 Mar 29.
Di Bisceglie AM, Lombardero M, Teckman J, Roberts L, Janssen HL, Belle SH, Hoofnagle JH; Hepatitis B Research Network (HBRN). Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat. 2017 Apr;24(4):320-329. doi: 10.1111/jvh.12643. Epub 2016 Dec 5.
Other Identifiers
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A-DK-3002-001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DK082864
Identifier Type: -
Identifier Source: org_study_id
NCT01306071
Identifier Type: -
Identifier Source: nct_alias
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