Observational Study of Persons With Hepatitis B Virus Infection in North America
- 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.
- To study individuals with hepatitis B and identify factors that affect the way the disease progresses.
- Individuals at least 18 years of age who have been diagnosed with hepatitis B.
- 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.
Chronic Hepatitis B e Antigen Positive
Chronic Hepatitis B e Antigen Negative
|Official Title:||Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)|
|Study Start Date:||February 2011|
|Contact: Elenita Rivera, R.N.||(301) email@example.com|
|Contact: Marc G Ghany, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Marc G Ghany, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|