Status:
COMPLETED
Hepatitis B Research Network Adult Cohort Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.
Detailed Description
Aims * Primary Aim: o To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and...
Eligibility Criteria
Inclusion
- The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.
- Inclusion criteria
- Written informed consent
- At least 18 years of age
- Hepatitis B surface antigen (HBsAg) positive and either:
- Pregnant
- Anti-Hepatitis D positive
- Diagnosed with acute Hepatitis B 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 (NCT01298037).
- Exclusion Criteria:
- Hepatic decompensation
- Hepatocellular carcinoma (HCC)
- Liver transplantation
- Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
- Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV) or Hepatitis C (HCV) co-infection are not excluded).
- Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
- Unable or unwilling to return for follow-up visits
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
2051 Patients enrolled
Trial Details
Trial ID
NCT01263587
Start Date
December 1 2010
End Date
June 9 2021
Last Update
May 31 2022
Active Locations (21)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
University of California San Francisco
San Francisco, California, United States, 94143