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NCT02845401 · ClinicalTrials.gov registry record · NA
The Hepatitis B e-Antigen Negative Disease - Directly Offered Study of Treatment Withdrawal in Patients With e-Antigen Negative Chronic HBV Infection (BeNEG-DO).
A NA study of Chronic Hepatitis B Virus, sponsored by California Pacific Medical Center Research Institute.
- Active
- Registry status
- NA
- Development phase
- 121
- Enrollment target
- 2
- Study locations
NCT02845401: Active NA study of Chronic Hepatitis B Virus, sponsored by California Pacific Medical Center Research Institute.
NCT02845401 is a NA study of Chronic Hepatitis B Virus that is active but no longer recruiting, run by California Pacific Medical Center Research Institute. The registered enrollment target is 121 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02845401, a NA study of Chronic Hepatitis B Virus, is active but no longer recruiting, sponsored by California Pacific Medical Center Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators' research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in developed countries is treated indefinitely with antiviral drugs. The investigators' study "BeNEG-DO," directly offers patients who are already taking standard oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or continue treatment. Drawing on data from pilot studies, including the investigators' own University of California, San Francisco and Sutter Institutional Review Board-approved study, the investigators will examine a finite HBV treatment strategy on clinical outcome and safety. In conjunction, the investigators will study immunologic mechanisms and gene expression profiles that correlate with and predict the post-treatment clinical course. The BeNEG-DO study could seriously question, and potentially change, the current treatment paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral therapeutics.
Conditions Studied
Interventions
- OTHER Stop NA therapy
Study Locations (2)
California
- California Pacific Medical Center - San Francisco
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2016-11-17 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT02845401 still lists
NCT02845401 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Chronic Hepatitis B Virus appearing as the primary indexed condition, and to 1 intervention - of which Stop NA therapy is the first listed.
NCT02845401 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02845401 about?
NCT02845401 is a clinical study titled "The Hepatitis B e-Antigen Negative Disease - Directly Offered Study of Treatment Withdrawal in Patients With e-Antigen Negative Chronic HBV Infection (BeNEG-DO).". The investigators' research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in develop...
What is the current status of trial NCT02845401?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 121 participants. The study started on 2016-11-17. Estimated completion is 2026-05-31.
What conditions does trial NCT02845401 study?
This clinical trial studies the following conditions: Chronic Hepatitis B Virus.
What interventions are being tested in trial NCT02845401?
The interventions under investigation include: Stop NA therapy (OTHER).
Who is sponsoring clinical trial NCT02845401?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02845401 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02845401's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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