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GSK3228836 for Hepatitis B

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
GSK Investigational Site, Ehime, JapanHepatitis BGSK3228836 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see how well a previous GSK3228836 treatment worked in the long term. No new treatment will be given.

Eligible Conditions
  • Hepatitis B

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Selgantolimod
1
Ultrasound + AFP
1
GSK3228836

Study Objectives

2 Primary · 24 Secondary · Reporting Duration: Months 0, 2.5, 9, 15, 21, 27, 33

Month 33
Change from Baseline for HBV RNA (log10 IU/ml)
Change from Baseline for HbcrAg (kU/mL)
Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL)
Month 33
Time from NA cessation to NA retreatment- NA controlled participants
Structure of choanae
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response
Time from NA cessation to the first occurrence of hepatitis B surface antigen (HBsAg) reversion or first use of any rescue medication- NA controlled participants
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response
Time from NA cessation to the loss of SVR-NA controlled participants
Month 33
Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment)
Sodium
Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR)
Month 33
Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants
Month 33
Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants
Month 0
Therapeutic procedure
Month 0
Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants
Month 6
Hepatitis B Surface Antigens
Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment)
Up to 33 months
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Absolute values for HbsAg, hepatitis B virus (HBV) DNA, hepatitis B e-antigen (HbeAg) (logarithm to the base 10 [log10] International units per milliliter [IU/mL])
Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])
Percentage of participants with anti-HBe (antibody to HBeAg)
Percentage of participants with anti-HBs (antibody to HBsAg)
Percentage of participants with mutations

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Selgantolimod
2
Ultrasound + AFP
2
GSK3228836

Trial Design

2 Treatment Groups

Nucleos(t)ide analogue (NA) naïve participants
1 of 2
NA controlled participants
1 of 2

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: GSK3228836 · No Placebo Group · Phase 2

Nucleos(t)ide analogue (NA) naïve participants
Drug
Experimental Group · 1 Intervention: GSK3228836 · Intervention Types: Drug
NA controlled participants
Drug
Experimental Group · 1 Intervention: GSK3228836 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IONIS-HBVRx
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: months 0, 2.5, 9, 15, 21, 27, 33

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,661 Previous Clinical Trials
7,949,905 Total Patients Enrolled
164 Trials studying Hepatitis B
338,972 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,568 Previous Clinical Trials
6,133,871 Total Patients Enrolled
128 Trials studying Hepatitis B
331,879 Patients Enrolled for Hepatitis B

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
What state do they live in?
Ontario100.0%
Why did patients apply to this trial?
  • "Would like to cure the recent blood test I had with Hep B"
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Average response time
  • < 2 Days
References

Frequently Asked Questions

Could you expound upon the potential risks of GSK3228836 for users?

"GSK3228836 was awarded a score of 2 due to available evidence which suggested that the drug is safe, but no clinical data demonstrating efficacy had been collected yet." - Anonymous Online Contributor

Unverified Answer

How many participants are engaged in the current clinical trial?

"Affirmative. Clinicaltrials.gov contains information which reveals that this clinical trial, originally posted on November 25th 2021, is currently enrolling participants. Altogether 450 individuals need to be recruited from two distinct sites." - Anonymous Online Contributor

Unverified Answer

Has GSK3228836 been evaluated in prior research projects?

"Currently, 3 studies are investigating GSK3228836; none of which in the final phase. London, Ontario is home to the majority of these clinical trials but other sites around 90 locations have been identified as well." - Anonymous Online Contributor

Unverified Answer

Are there opportunities for new participants to join this clinical trial?

"According to clinicaltrials.gov, this research endeavour is actively seeking participants; the trial was initially listed on November 25th 2021 and its contents were recently updated a year later on November 24th 2022." - Anonymous Online Contributor

Unverified Answer

Is this a pioneering research endeavor?

"The investigation of GSK3228836 officially began in 2020, when GlaxoSmithKline funded the first trial involving 20 participants. After being granted Phase 2 drug approval later that year, there are currently 3 ongoing studies for this medication spread out across 19 different nations and 18 cities." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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