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NA therapy

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

N/A

Waitlist Available

Led By Stewart L Cooper, MD

Research Sponsored by California Pacific Medical Center Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Otherwise healthy with no serious co-morbidities

Age 18-67

Must not have

HBeAg-CHB with virologic breakthrough while on NA therapy during the prior 192 weeks (3.7 years)

A documented history of extrahepatic manifestations of hepatitis B, including renal disease and/or vasculitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with the early antigen negative form of chronic hepatitis B who have been on antiviral drugs for at least 192 weeks. The trial offers the option to stop or continue treatment to see if there are any clinical differences and what the mechanisms and gene expression profiles are that correlate with the clinical course.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves stopping antiviral medication rather than starting a new one, side effects are related to potential hepatitis B flare-ups upon cessation which could include jaundice (yellowing skin/eyes), fatigue, abdominal pain and elevated liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am generally healthy with no serious health issues.

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I am between 18 and 67 years old.

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My liver function and platelet count are normal.

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I have chronic hepatitis B with over 3.7 years of successful treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I am younger than 18 or older than 67.

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I am willing and able to restart antiviral treatment when told by a doctor.

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My liver has significant scarring.

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I have had a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serologic response and rate: HBsAg persistence versus loss; HBsAb production (+/-). This clinically relevant endpoint evaluates chronic HBV clearance and persistence

Secondary study objectives

Case retreatment rate

Liver biochemical response: ALT level

Virologic response: HBV DNA level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met