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Virus Therapy

GSK3228836 for Chronic Hepatitis B (B-Fine Trial)

Q: Does this investigation accept new participants?

Affirmative. According to clinicaltrials.gov, this ongoing research trial was initially posted on October 6th 2020 and has most recently been updated on August 24th 2022 seeking 20 participants from two sites.

Q: Is this investigation unique in its design and approach?

GSK3228836 is being tested in 3 clinical trials, which span 19 countries and 18 cities. The inaugural study commenced in 2020 and was hosted by GlaxoSmithKline; it included 20 participants who successfully conclude Phase 2 of the drug approval stage. Since then, three additional investigations have been conducted.

Q: What is the aggregate amount of participants joining this medical experiment?

Affirmative. Clinicaltrials.gov data shows that this medical trial, which was originally posted on October 6th 2020, is actively looking for participants. The study has a target of 20 patients across 2 different sites.

Q: Are there any other precedents of research studies that have incorporated GSK3228836?

Presently, there are 3 trials analyzing GSK3228836. None of these active projects have reached Phase 3 yet. The majority of research is happening in Jilin and Majadahonda (Madrid), but the treatment is also being studied across 90 other sites worldwide.

Q: Are there any potential perils associated with GSK3228836?

Assigning a value of 2, our team at Power believes that GSK3228836 is moderately safe based on the fact that it has already undergone Phase 2 clinical trials and thus has some preliminary data to support its safety but not efficacy.

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 week -1, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 16, week 20, week 24, week 28, week 32 and week 36

Awards & highlights

B-Fine Trial Summary

This trial is looking at a new treatment for hepatitis B, to see if it is effective and has any immunomodulatory properties.

Eligible Conditions

Hepatitis B

B-Fine Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week -1, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 16, week 20, week 24, week 28, week 32 and week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week -1, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 16, week 20, week 24, week 28, week 32 and week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -1, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 16, week 20, week 24, week 28, week 32 and week 36 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 achieving serum HBsAg level less than (<) lower limit of quantitation (LLOQ)

Secondary outcome measures

Actual values of HB surface antibody (anti-HBsAg) levels at indicated time points

Actual values of HBV DNA at indicated time points

Actual values of HBe antibody (anti-HBeAg) levels at indicated time points

+11 more

B-Fine Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants receiving 300 mg GSK3228836Experimental Treatment2 Interventions

Eligible participants on stable nucleos(t)ide therapy will receive GSK3228836 300 mg subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IONIS-HBVRx

Not yet FDA approved

Nucleos(t)ide therapy

2020

Completed Phase 2

~460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,751 Previous Clinical Trials

8,067,460 Total Patients Enrolled

165 Trials studying Hepatitis B

340,294 Patients Enrolled for Hepatitis B

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,918 Total Patients Enrolled

129 Trials studying Hepatitis B

333,201 Patients Enrolled for Hepatitis B

Media Library

GSK3228836 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04544956 — Phase 2

Hepatitis B Research Study Groups: Participants receiving 300 mg GSK3228836

Hepatitis B Clinical Trial 2023: GSK3228836 Highlights & Side Effects. Trial Name: NCT04544956 — Phase 2

GSK3228836 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544956 — Phase 2

Frequently Asked Questions

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

Does this investigation accept new participants?

"Affirmative. According to clinicaltrials.gov, this ongoing research trial was initially posted on October 6th 2020 and has most recently been updated on August 24th 2022 seeking 20 participants from two sites."

Answered by AI

Is this investigation unique in its design and approach?

"GSK3228836 is being tested in 3 clinical trials, which span 19 countries and 18 cities. The inaugural study commenced in 2020 and was hosted by GlaxoSmithKline; it included 20 participants who successfully conclude Phase 2 of the drug approval stage. Since then, three additional investigations have been conducted."

Answered by AI

What is the aggregate amount of participants joining this medical experiment?

"Affirmative. Clinicaltrials.gov data shows that this medical trial, which was originally posted on October 6th 2020, is actively looking for participants. The study has a target of 20 patients across 2 different sites."

Answered by AI

Are there any other precedents of research studies that have incorporated GSK3228836?

"Presently, there are 3 trials analyzing GSK3228836. None of these active projects have reached Phase 3 yet. The majority of research is happening in Jilin and Majadahonda (Madrid), but the treatment is also being studied across 90 other sites worldwide."

Answered by AI

Are there any potential perils associated with GSK3228836?

"Assigning a value of 2, our team at Power believes that GSK3228836 is moderately safe based on the fact that it has already undergone Phase 2 clinical trials and thus has some preliminary data to support its safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B

2020. "A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544956.

All > Autoimmune Hepatitis > Hepatitis B