Chronic Hepatitis B e Antigen Negative Clinical Trial
Official title:
Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Billerbeck E, Bottler T, Thimme R. Regulatory T cells in viral hepatitis. World J Gastroenterol. 2007 Sep 28;13(36):4858-64. Review. — View Citation
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. — View Citation
Visvanathan K, Lewin SR. Immunopathogenesis: role of innate and adaptive immune responses. Semin Liver Dis. 2006 May;26(2):104-15. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To describe participants with hepatitis |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01581554 -
Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
|
||
| Active, not recruiting |
NCT01821794 -
Tenofovir DF With or Without Peginterferon for Chronic Hepatitis B
|
Phase 3 |