Stopping Antiviral Therapy for Chronic Hepatitis B
(BeNEG-DO Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byStewart Cooper, Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: California Pacific Medical Center Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-67 with e-Antigen negative chronic Hepatitis B who've been on antiviral therapy for at least 3.7 years, have no serious liver damage or other major health issues, and can restart treatment if needed. It's not for those with advanced liver fibrosis, abnormal liver tests, cirrhosis suspicion, prior transplants, recent immunosuppressive therapy use, pregnancy or significant co-morbidities.

Inclusion Criteria

I am generally healthy with no serious health issues.

I am ready to restart antiviral treatment when told by a doctor.

I am between 18 and 67 years old.

+3 more

Exclusion Criteria

I have hepatitis B and my treatment in the last 3.7 years hasn't stopped the virus.

I have had kidney problems or blood vessel inflammation due to hepatitis B.

A close family member had liver cancer due to hepatitis B.

+9 more

Participant Groups

The BeNEG-DO study offers patients the choice to stop or continue their ongoing oral HBV antiviral treatment after a minimum of 192 weeks. The aim is to assess the effects of ending treatment on clinical outcomes and safety while exploring immune responses and genetic markers that may predict post-treatment results.

2Treatment groups

Experimental Treatment

Active Control

Group I: HBeAg-CHB patients who stop NA TherapyExperimental Treatment1 Intervention

Patients with early antigen negative form of disease (HBeAg-CHB) who are already taking standard oral HBV antiviral therapy for at least 192 weeks that stop treatment. Intervention: Cases will stop antiviral therapy

Group II: HBeAg-CHB patients continue NA TherapyActive Control1 Intervention

Patients with early antigen negative form of disease (HBeAg-CHB) who are already taking standard oral HBV antiviral therapy for at least 192 weeks that continue to stay on treatment. Intervention: None. Controls will continue antiviral therapy.