Hepatitis B Research Network Adult Cohort Study



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/8/2018
Start Date:December 2010
End Date:May 2020
Contact:Frani M Averbach, MPH
Email:HBRNDCC@edc.pitt.edu
Phone:412-624-3773

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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.

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
We found this trial at
21
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-1098
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-7562
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Boston, MA
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Phone: 214-820-2956
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-8999
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-936-7511
University of Michigan Health System The University of Michigan is home to one of the...
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Bethesda, Maryland 20892
Phone: 301-402-5115
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Bethesda, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-2516
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Dallas, Texas 75390
Phone: 214-645-6110
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-668-2673
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Honolulu, Hawaii 96813
Phone: 808-691-7609
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Honolulu, HI
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Phone: 804-828-4060
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Rochester, Minnesota 55905
Phone: 507-538-4877
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Saint Louis, Missouri 63110
Phone: 314-577-8551
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Saint Louis, Missouri 63110
Phone: 314-747-3969
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-1530
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94143
Phone: 415-476-2227
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Seattle, Washington 98101
(888) 862-2737
Phone: 206-341-1452
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Phone: 206-598-4956
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Toronto, Ontario
Phone: 416-603-5800
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