Status:
COMPLETED
Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
Background: Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who ha...
Detailed Description
Reactivation of hepatitis B is well known to occur with immunosuppression as in the setting of high dose immunosuppressive therapy, cancer chemotherapy and bone marrow or stem cell transplantation. It...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adult patients (greater than or equal to 18 years) with CHC who underwent treatment with an Interferon-free DAA-based therapy.
- Evidence of resolved HBV infection prior to starting interferon-free DAAbased therapy (HBsAg-negative with positive anti-HBc +/- positive anti-HBs)
- EXCLUSION CRITERIA:
- \- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of interferon-free DAA therapy
Exclusion
Key Trial Info
Start Date :
June 3 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03248622
Start Date
June 3 2017
End Date
May 28 2019
Last Update
November 30 2023
Active Locations (1)
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1
National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)
Bethesda, Maryland, United States, 20892