Bethesda, Maryland 20892


Purpose:

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.


Study 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.


Criteria:

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


NCT ID:

NCT01306071


Primary Contact:

Principal Investigator
Marc G Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Marc G Ghany, M.D.
Phone: (301) 402-5115
Email: mg228m@nih.gov


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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