Hepatitis B Research Network Adult Cohort Study

Hepatitis B Clinical Trial

— HBRN  

Official title:

Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263587
• Other study ID #: DK082864
• Secondary ID: U01DK082864U01DK
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

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

External Links

•   The Hepatitis B Research Network study web site