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

Study ID
110108

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact


Principal Investigator

Official Title

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

Brief Overview


Background:

- Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end
stage liver disease and liver cancer. Although significant progress has been made recently
in hepatitis B therapy, current knowledge about how to manage the infection is limited
because most treatment trials involve 1 to 2 years of therapy at most, even though most
patients require treatment of much longer duration for optimal long-term outcome. To improve
current knowledge on the disease and long-term disease progression, the Hepatitis B Research
Network is collecting health and disease information from individuals who have been
diagnosed with hepatitis B.

Objectives:

- To study individuals with hepatitis B and identify factors that affect the way the disease
progresses.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with hepatitis B.

Design:

- Participants will be screened with a physical examination and medical history. Health
information will be collected through questionnaires and surveys on health behaviors,
and family history of liver disease. Participants will also provide blood samples, and
those who have had a liver biopsy within the past 2 years or have one during the course
of the study will provide biopsy material for further study.

- Information will be collected during a series of study visits. Each visit will take
approximately 1 hour. During the first year, participants will have study visits 12
weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years,
participants will have a study visit approximately every 24 weeks (6 months) until the
end of the study.

- Additional visits will be required of women who are pregnant when enrolled in the study
or become pregnant during the course of the study.

- Participants whose hepatitis B status changes during the course of the study (for
example, a flare of disease activity) may be asked to return for more frequent visits.

Summary


Chronic hepatitis B virus infection is a leading cause of morbidity and mortality due to end
stage liver disease and liver cancer. Although significant progress has been made in
hepatitis B therapy, current knowledge about how to manage the infection is limited. To
improve current knowledge on the disease and long-term disease progression, the Hepatitis B
Research Network is collecting health and disease information from individuals who have been
diagnosed with hepatitis B.

The objectives of this study are to study individuals with acute and chronic hepatitis B to
identify factors that affect disease progression. Individuals at least 18 years of age who
have been diagnosed with hepatitis B will be eligible to participate. Participants will be
screened with a physical examination and medical history. Health information will be
collected through questionnaires and surveys on health behaviors and family history of liver
disease. Participants will also provide blood samples, and those who have had a liver biopsy
within the past 2 years or have one during the course of the study will be asked to provide
biopsy material for further study. Information will be collected during a series of study
visits, and additional visits will be required of women who are pregnant when enrolled in
the study or become pregnant during the course of the study. Participants whose hepatitis B
status changes during the course of the study (for example, a flare of disease activity) may
be asked to return for more frequent visits and may be eligible for treatment trials within
the network.

Participant Eligibility


- INCLUSION CRITERIA:

- Written informed consent

- At least 18 years of age

- HBsAg-positive and either

- Pregnant

- Anti-HDV positive

- Diagnosed with acute HBV 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.

EXCLUSION CRITERIA:

- History of hepatic decompensation

- Hepatocellular carcinoma (HCC)

- History of solid organ transplantation or bone marrow transplantation

- Chronic immunosuppression therapy

- Current hepatitis B antiviral treatment (except pregnant women and patients who are
anti-HDV positive)

- Known HIV co-infection (patients with HDV or HCV co-infection are not excluded).

- Medical or social condition which, in the opinion of the investigator, would make the
patient unsuitable for the study or interfere with or prevent follow-up per protocol

- Unable or unwilling to return for follow-up visits