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Hepatitis B Research Network Adult Cohort Study (HBRN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263587
Recruitment Status : Recruiting
First Posted : December 20, 2010
Last Update Posted : January 6, 2020
Sponsor:
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

Tracking Information
First Submitted Date December 14, 2010
First Posted Date December 20, 2010
Last Update Posted Date January 6, 2020
Study Start Date December 2010
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2011)
  • 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.
Original Primary Outcome Measures
 (submitted: December 17, 2010)
  • Hepatitis Exacerbation marked by 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 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 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 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 ]
    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 Assocation 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 HCC will be recorded. Follow-up ends with liver transplantation.
Change History Complete list of historical versions of study NCT01263587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatitis B Research Network Adult Cohort Study
Official Title Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Liver biopsy tissue, blood (serum, plasma, and DNA)
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.
Condition Hepatitis B
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 17, 2010)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Frani M Averbach, MPH 412-624-3773 HBRNDCC@edc.pitt.edu
Contact: Andrew J. Pelesko, BS 412-383-9584 HBRNDCC@edc.pitt.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01263587
Other Study ID Numbers DK082864
U01DK082864 ( U.S. NIH Grant/Contract )
U01DK082843 ( U.S. NIH Grant/Contract )
U01DK082866 ( U.S. NIH Grant/Contract )
U01DK082863 ( U.S. NIH Grant/Contract )
U01DK082867 ( U.S. NIH Grant/Contract )
U01DK082871 ( U.S. NIH Grant/Contract )
U01DK082872 ( U.S. NIH Grant/Contract )
U01DK082874 ( U.S. NIH Grant/Contract )
U01DK082919 ( U.S. NIH Grant/Contract )
U01DK082923 ( U.S. NIH Grant/Contract )
U01DK082927 ( U.S. NIH Grant/Contract )
U01DK082943 ( U.S. NIH Grant/Contract )
U01DK082944 ( U.S. NIH Grant/Contract )
P30DK050306 ( U.S. NIH Grant/Contract )
A-DK-3002-001 ( Other Grant/Funding Number: Interagency agreement )
M01RR000040 ( U.S. NIH Grant/Contract )
UL1TR000058 ( U.S. NIH Grant/Contract )
UL1TR000004 ( U.S. NIH Grant/Contract )
UL1RR024986 ( U.S. NIH Grant/Contract )
UL1TR001111 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anna Lok, University of Michigan
Study Sponsor University of Pittsburgh
Collaborators
  • 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
PRS Account University of Pittsburgh
Verification Date January 2020