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NCT03248622 · ClinicalTrials.gov registry record
Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 79
- Enrollment target
NCT03248622: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03248622 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 79 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03248622 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 79 participants
- Enrollment target
Study 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.
Primary Outcome
Detection of HBV DNA or HBsAg and elevated ALT level
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2017-06-03 |
| Est. Completion | 2019-05-28 |
What the finished NCT03248622 record still lists
NCT03248622 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 79 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03248622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03248622 about?
NCT03248622 is a clinical study titled "Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection". 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 dire...
What is the current status of trial NCT03248622?
This trial is currently completed. The enrollment target is 79 participants. The study started on 2017-06-03. Estimated completion is 2019-05-28.
Who is sponsoring clinical trial NCT03248622?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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