An observational study in Hepatitis B, sponsored by University of Pittsburgh. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by University of Pittsburgh · Observational
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.
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:
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's enrollment of 2,051 is above the median of 395 across 410 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Hepatitis B surface antigen (HBsAg) positive and either:
Exclusion Criteria:
Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare
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.
Time frame: up to 288 weeks
Antigen loss: e and s
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.
Time frame: up to 288 weeks
Cirrhosis
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.
Time frame: up to 288 weeks
Hepatic decompensation
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.
Time frame: up to 288 weeks
Hepatocellular carcinoma (HCC)
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.
Time frame: up to 288 weeks
Death
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.
Time frame: up to 288 weeks
Liver transplantation
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.
Time frame: up to 288 weeks
Plan to share: No
The record gives a start of Dec 2010, a primary completion of Jun 2021 and a completion of Jun 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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