Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection

NCT03248622 | Completed

• 2 other identifiers: 99991709917-DK-N099
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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 had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected. Objectives: To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy. Eligibility: Data were collected from adults 18 and older in studies that were done in 2012 and 2016. Design: Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment. Researchers will take data from those records. This will include data on:

• Age, sex, race, and ethnicity
• Treatment and disease status
• Lab results Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.

Conditions

Hepatitis B

Keywords

Incidence; Hepatitis B Surface Antigen; Decompensation

Outcome Measures

Primary Outcomes (1)

• The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection.

  Detection of HBV DNA or HBsAg and elevated ALT level

  From initiation of treatment to 24 weeks post-treatment

Study Arms (2)

Anti-HBc positive

Anti-HBc positive

HCV positive Cohort

HCV positive Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis C who were anti-HBc positive and who received treatment with a direct acting antiviral agent.

You may qualify if:

• 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)

You may not qualify if:

• \- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of interferon-free DAA therapy

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Marc G Ghany, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 14, 2017
• Study Start: June 3, 2017
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)