Hepatitis B Research Network Adult Cohort Study (HBRN)
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| ClinicalTrials.gov Identifier: NCT01263587 |
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Recruitment Status :
Active, not recruiting
First Posted : December 20, 2010
Last Update Posted : November 9, 2020
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Sponsor:
University of Pittsburgh
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Anna Lok, University of Michigan
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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.
| Condition or disease |
|---|
| Hepatitis B |
Aims
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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
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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 |
| Estimated Enrollment : | 2500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study) |
| Study Start Date : | December 2010 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | May 31, 2021 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Liver biopsy tissue, blood (serum, plasma, and DNA)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263587
Locations
Show 21 study locations
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Investigators
| Principal Investigator: | Steven Belle, PhD | University of Pittsburgh |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by Anna Lok, University of Michigan:
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Hepatitis B HBV Cohort Study |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |