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Completed

NCT Number: NCT01263587

Hepatitis B Research Network Adult 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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital Liver Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HBRN

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2010
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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