Hepatitis B Research Network Adult Cohort Study (HBRN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01263587
First received: December 14, 2010
Last updated: May 7, 2014
Last verified: May 2014

December 14, 2010
May 7, 2014
December 2010
May 2015   (final data collection date for primary outcome measure)
  • Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Hepatitis Exacerbation marked by ALT Flare [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    Once cirrhosis is diagnosed, follow-up will include hepatocellural carcinoma (HCC) surveillance. HCC surveillance will also be performed in non-cirrhotic participants who meet American Assocaition for the Study of Liver Disease (95) guidelines criteria.
  • Hepatic decompensation [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Hepatocellular carcinoma HCC may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Assocation for the Study of Liver Disease criteria.
  • Death [ Time Frame: up to 288 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental HCC will be recorded. Follow-up ends with liver transplantation.
Complete list of historical versions of study NCT01263587 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hepatitis B Research Network Adult Cohort Study
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Liver biopsy tissue, blood (serum, plasma, and DNA)

Non-Probability Sample

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

Hepatitis B
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michelle E Danielson, PhD 412-625-5555 danielsonm@edc.pitt.edu
Contact: Joan MacGregor, MS 412-624-4300 macgreg@edc.pitt.edu
United States,   Canada
 
NCT01263587
DK082864, U01DK082864
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven Belle, PhD University of Pittsburgh
University of Pittsburgh
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP