Hepatitis B Research Network Adult Cohort Study (HBRN)

May 26, 2022 updated by: Anna Lok, University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2051

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Western Hospital Liver Centre
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medial Center
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • NIH Clinical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare
Time Frame: up to 288 weeks
A flare is defined as serum ALT greater than or equal to 10 times the upper limit of normal which corresponds to 300 IU/L in males or 200 IU/L in females. This definition will also be applied to hepatitis B surface antigen (HBsAg) positive pregnant women whose ALT levels increase during pregnancy or postpartum. Once a flare is detected, participants will be followed more closely until its resolution.
up to 288 weeks
Antigen loss: e and s
Time Frame: up to 288 weeks
Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.
up to 288 weeks
Cirrhosis
Time Frame: up to 288 weeks
Once cirrhosis is diagnosed, follow-up will include hepatocellular carcinoma (HCC) surveillance. HCC surveillance will also be performed in non-cirrhotic participants who meet American Association for the Study of Liver Disease guidelines criteria.
up to 288 weeks
Hepatic decompensation
Time Frame: up to 288 weeks

Development of hepatic decompensation will be defined by any of the following events:

  • Ascites or hepatic hydrothorax
  • Variceal or portal hypertensive bleeding
  • Hepatic encephalopathy
  • Child-Turcotte-Pugh (CTP) score of 7 or above

It is anticipated that there will be a small number of participants who will develop hepatic decompensation during follow-up.
up to 288 weeks
Hepatocellular carcinoma (HCC)
Time Frame: up to 288 weeks
Hepatocellular carcinoma (HCC) may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
up to 288 weeks
Death
Time Frame: up to 288 weeks
Death may occur related to liver disease (typically hepatic decompensation or Hepatocellular carcinoma) or may occur unrelated to hepatitis B or liver disease. Date and cause of death will be recorded.
up to 288 weeks
Liver transplantation
Time Frame: up to 288 weeks
Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental Hepatocellular carcinoma (HCC) will be recorded. Follow-up ends with liver transplantation.
up to 288 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 9, 2021

Study Completion (Actual)

June 9, 2021

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 20, 2010

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK082864
  • UL1RR024986 (U.S. NIH Grant/Contract)
  • UL1TR001111 (U.S. NIH Grant/Contract)
  • U01DK082864 (U.S. NIH Grant/Contract)
  • U01DK082874 (U.S. NIH Grant/Contract)
  • U01DK082944 (U.S. NIH Grant/Contract)
  • U01DK082843 (U.S. NIH Grant/Contract)
  • U01DK082871 (U.S. NIH Grant/Contract)
  • UL1TR000004 (U.S. NIH Grant/Contract)
  • A-DK-3002-001 (Other Grant/Funding Number: Interagency agreement with NIDDK)
  • U01DK082863 (U.S. NIH Grant/Contract)
  • U01DK082866 (U.S. NIH Grant/Contract)
  • U01DK082867 (U.S. NIH Grant/Contract)
  • U01DK082872 (U.S. NIH Grant/Contract)
  • U01DK082919 (U.S. NIH Grant/Contract)
  • U01DK082923 (U.S. NIH Grant/Contract)
  • U01DK082927 (U.S. NIH Grant/Contract)
  • U01DK082943 (U.S. NIH Grant/Contract)
  • UL1TR000058 (U.S. NIH Grant/Contract)
  • P30DK050306 (U.S. NIH Grant/Contract)
  • M01RR000040 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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