Protocol Details
Observational Study of Persons with Hepatitis B Virus Infection in North America (Cohort Study)
This study is NOT currently recruiting participants.
Summary
Number |
11-DK-0108 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 100 |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Cirrhosis;
Natural History;
Hepatitis B;
Natural History |
Recruitment Keyword(s) |
Hepatitis B |
Condition(s) |
Chronic Hepatitis B e Antigen Positive;
Chronic Hepatitis B e Antigen Negative |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Diabetes and Digestive and Kidney Diseases |
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.
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.
OR completed the HBRN Adult Immune Active trial (regardless of HBsAg status)
EXCLUSION CRITERIA:
-History of hepatic decompensation on clinical or laboratory criteria
-Hepatocellular carcinoma (HCC)
-History of solid organ transplantation or bone marrow transplantation
-Current hepatitis B antiviral treatment (except pregnant women, patients who are anti-HDV positive, and participants who completed the HBRN Adult Immune Active trial)
-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
Citations:
Harrison TJ. Hepatitis B virus: molecular virology and common mutants. Semin Liver Dis. 2006 May;26(2):87-96. Review. Erratum in: Semin Liver Dis. 2006 Aug;26(3):304-5.
Billerbeck E, Bottler T, Thimme R. Regulatory T cells in viral hepatitis. World J Gastroenterol. 2007 Sep 28;13(36):4858-64.
Visvanathan K, Lewin SR. Immunopathogenesis: role of innate and adaptive immune responses. Semin Liver Dis. 2006 May;26(2):104-15.
Contacts:
Clinical Trials Number:
NCT01263587