Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Study Overview
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Brief Summary
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This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

Official Title
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A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: GSK3228836


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participants who have previously received at least one dose of GSK3228836 and Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule. Capable of giving signed informed consent. Exclusion Criteria: Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nucleos(t)ide analogue (NA) naïve participants<br>Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study. | Drug: GSK3228836<br>* No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.<br>|
| Experimental: NA controlled participants<br>Participants who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods. NA cessation at 3 months. No study treatment will be administered in this study. | Drug: GSK3228836<br>* No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | NA indicates Nucleos(t)ide analogue (NA) | From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33) | 
| Time from NA cessation to the loss of SVR-NA controlled participants |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from NA cessation to NA retreatment- NA controlled participants |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants |  | From primary endpoint assessment in the previous GSK 3228836 study up to End of Study (Month 33) | 
| Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants |  | Months 0, 3, 9, 15, 21, 27, 33 | 
| Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR) |  | From date of achieving SVR up to End of Study (Month 33) | 
| Percentage of participants with delayed SVR in the absence of any rescue medication after end of the parent study (NA controlled participants continuing NA treatment) |  | Months 0, 2.5, 9, 15, 21, 27, 33 | 
| Time to the loss of SVR from time of achieving delayed SVR (NA controlled participants continuing NA treatment) |  | From date of achieving SVR up to End of Study (Month 33) | 
| Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment) |  | Months 6, 9, 15, 21, 27, 33 | 
| Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment) |  | From date of achieving SVR up to End of Study (Month 33) | 
| Percentage of participants with HBsAg loss in the absence of any rescue medication after NA cessation- NA controlled participants with partial response |  | Months 6, 9, 15, 21, 27, 33 | 
| Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Time from NA cessation to the first occurrence of NA retreatment- NA controlled participants with partial response |  | From Visit 3 (Month 3) up to End of Study (Month 33) | 
| Percentage of participants with anti-HBs (antibody to HBsAg) |  | Up to 33 months | 
| Percentage of participants with anti-HBe (antibody to HBeAg) |  | Up to 33 months | 
| 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]) |  | Up to 33 months | 
| Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL) |  | Baseline and up to 33 months | 
| Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL]) |  | Up to 33 months | 
| Change from Baseline for HbcrAg (kU/mL) |  | Baseline and up to 33 months | 
| Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml) |  | Up to 33 months | 
| Change from Baseline for HBV RNA (log10 IU/ml) |  | Baseline and up to 33 months | 
| Percentage of participants with mutations |  | Up to 33 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK3228836, B-Sure, Nucleos(t)ide, Sustained virologic response, durability