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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01263587
Other study ID # DK082864
Secondary ID U01DK082864U01DK
Status Completed
Phase
First received
Last updated
Start date December 2010
Est. completion date June 9, 2021

Study information

Verified date May 2022
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT01306071

Recruitment information / eligibility

Status Completed
Enrollment 2051
Est. completion date June 9, 2021
Est. primary completion date June 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Toronto Western Hospital Liver Centre Toronto Ontario
United States University of Michigan Health System Ann Arbor Michigan
United States NIH Clinical Center Bethesda Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States Baylor University Medical Center Dallas Texas
United States University of Texas Southwestern Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States The Queen's Medial Center Honolulu Hawaii
United States Cedars Sinai Medical Center Los Angeles California
United States University of California Los Angeles Los Angeles California
United States University of Minnesota Minneapolis Minnesota
United States Virginia Commonwealth University Medical Center Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Saint Louis University Saint Louis Missouri
United States Washington University Saint Louis Missouri
United States California Pacific Medical Center San Francisco California
United States University of California San Francisco San Francisco California
United States Harborview Medical Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Pittsburgh National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 288 weeks
Primary 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. up to 288 weeks
Primary 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. up to 288 weeks
Primary 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.
up to 288 weeks
Primary 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. up to 288 weeks
Primary 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. up to 288 weeks
Primary 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. up to 288 weeks
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