← Back to Search

Antiviral Agent

NA therapy for Hepatitis B (B-Together Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from off-treatment week 1 to off-treatment week 24
Awards & highlights

B-Together Trial Summary

This trial will study if a longer treatment of GSK3228836 followed by pegylated interferon can increase the rate of hepatitis B surface antigen loss in participants who are already taking nucleos(t)ide analogue therapy, and whether the virologic response can be sustained once PegIFN treatment is discontinued.

Eligible Conditions
  • Hepatitis B

B-Together Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from off-treatment week 1 to off-treatment week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from off-treatment week 1 to off-treatment week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants who achieve sustained virologic response (SVR) for 24 weeks after end of treatment
Secondary outcome measures
Absolute values of ALT
Absolute values of HBV DNA levels
Absolute values of HBe antibody levels
+12 more

B-Together Trial Design

2Treatment groups
Experimental Treatment
Group I: GSK3228836 for 24 weeks + PegIFN for up to 24 weeksExperimental Treatment3 Interventions
Eligible participants on stable NA therapy will receive GSK3228836 for 24 weeks, followed by up to 24 weeks of PegIFN.
Group II: GSK3228836 for 12 weeks + PegIFN for up to 24 weeksExperimental Treatment3 Interventions
Eligible participants on stable NA therapy will receive GSK3228836 for 12 weeks, followed by up to 24 weeks of PegIFN.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3228836
2020
Completed Phase 2
~590
PegIFN
2021
Completed Phase 2
~110
NA therapy
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,344 Total Patients Enrolled
165 Trials studying Hepatitis B
340,198 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,822 Total Patients Enrolled
129 Trials studying Hepatitis B
333,105 Patients Enrolled for Hepatitis B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a lot of sites participating in this research project in North America?

"To limit the burden of travel, it is encouraged that participants select a study site location from the 7 available options that is closest to them. The clinical trial sites are situated in Calgary, New york, Sacramento and 4 other locations."

Answered by AI

How can I sign up to be a part of this research project?

"This study is recruiting 108 people, within the ages of 18 and 75 who currently have hepatitis b. It is important that patients also meet the following criteria: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: a) Refrain from donating sperm; b) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agree to use contraception/barrier: Agree to use a male condom (and should also be advised of the"

Answered by AI

Does the FDA endorse NA therapy?

"Although there is some evidence to support the safety of this therapy, as it is only a Phase 2 trial, Power rates it at a 2."

Answered by AI

How does this research on NA therapy compare to other work in the field?

"NA therapy is being researched in 3 ongoing clinical trials, 0 of which are Phase 3. Most of the research for this therapy is taking place in London, Ontario; however, 89 other locations are also running clinical trials concerning NA therapy."

Answered by AI

Are there other research projects like this one?

"NA therapy has been studied since 2020. The first trial was completed in 2020 and was sponsored by GlaxoSmithKline. Following the first study in 2020, which involved 20 patients, NA therapy received its Phase 2 drug approval. Today there are 3 active studies for NA therapy across 18 cities and 19 countries."

Answered by AI

How many people fit the qualifications for this research project?

"This study is not recruiting patients at the moment, though it was active from January 28th, 2021 to November 4th, 2022. If you're interested in other studies like this one, there are 297 clinical trials for hepatitis b and 3 NA therapy trials that are currently looking for participants."

Answered by AI

Does this research include elderly individuals as participants?

"This study requires that patients between the ages of 18-75 apply. There are 30 studies available for minors and 252 for elderly patients."

Answered by AI

Are new participants being accepted into this study?

"This particular trial is no longer recruiting patients. The clinical study was first advertised on January 28th, 2021 and the most recent update was November 4th, 2022. However, there are other ongoing trials that might be of interest; for example, 297 studies related to hepatitis b and 3 NA therapy trials are currently looking for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
2021. "Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676724.
~26 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top