Hepatitis B Research Network Adult Cohort Study

Completed

• Conditions: Hepatitis B

• Registration Number: NCT01263587
• Lead Sponsor: University of Pittsburgh

Brief 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.

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2051

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare	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.
Antigen loss: e and s	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.
Hepatic decompensation	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.
Cirrhosis	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.
Hepatocellular carcinoma (HCC)	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.
Death	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.
Liver transplantation	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.

Trial Locations

Locations (21)

The Queen's Medial Center; 🇺🇸 Honolulu, Hawaii, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, 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

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

NIH Clinical Center; 🇺🇸 Bethesda, Maryland, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, 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

Toronto Western Hospital Liver Centre; 🇨🇦 Toronto, Ontario, Canada

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States