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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506867-33 | Other Identifier | EU CT Number |
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This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear [209668: NCT04449029], B-Together [209348: NCT04676724], B-Fine [212602: NCT04544956], B-Well 1 [202009: NCT05630807], B-Well 2 [219288: NCT05630820], and TH HBV ASO-001 [217023: NCT05276297]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Not-on-NA participants | Experimental | Participants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study. |
|
| On-NA participants | Experimental | Participants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study. |
|
| NA-cessated participants | Experimental | Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepirovirsen | Drug | No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO) | NA indicates nucleos(t)ide analogue (NA). | From primary endpoint assessment in the parent study up to Month 57 |
| Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882 | From Month 3 up to Month 57 | |
| Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882 | From Month 3 up to Month 33 | |
| Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study | From primary endpoint assessment in the parent study up to Month 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have hepatitis B surface antigen (HBsAg) reversion or use of any rescue medication after NA cessation (in either parent study or study 206682) | Up to Month 57 | |
| Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have virologic relapse or use of any rescue medication after NA cessation (in either parent study or study 206682) |
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Inclusion criteria:
For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
Participants who have previously received at least one dose of bepirovirsen AND
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sacramento | California | 95817 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| Placebo | Drug | No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies. |
|
| Up to Month 57 |
| Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have clinical relapse or use of any rescue medication after NA cessation (in either parent study or study 206682) | Up to Month 57 |
| Percentage of On-NA and NA-cessated participants with PSPO in the parent study who receive NA retreatment after NA cessation (in either parent study or study 206682) | Up to Month 57 |
| Percentage of On-NA participants with PSPO in the parent study, who continue NA treatment in study 206882, and have no loss of treatment response | From primary endpoint assessment in the parent study up to Month 33 |
| Percentage of Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 in absence of rescue medication after end of treatment in the parent study | Up to Month 57 |
| Time to loss of FC from time of achieving delayed FC in Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 | From date of achieving delayed FC up to Month 57 |
| Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have a delayed FC in 206882 in absence of rescue medication after end of treatment in the parent study | Up to Month 57 |
| Time to loss of FC in On-NA participants who achieve a partial response in the parent study, discontinue NA treatment in study 206882 and achieve delayed FC in 206882 | From date of achieving delayed FC up to Month 57 |
| Percentage of On-NA participants with a partial response in the parent study, who do not discontinue NA treatment in study 206882, and have a delayed treatment response in 206882 in absence of rescue medication after end of treatment in the parent study | Up to Month 33 |
| Time to loss of treatment response in On-NA participants who achieve a partial response in the parent study, do not discontinue NA treatment in study 206882 and have a delayed treatment response in 206882 | From date of achieving delayed treatment response up to Month 33 |
| Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have HBsAg loss in the absence of any rescue medication after NA cessation in 206882 | From Month 3 to Month 57 |
| Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have virologic relapse or use of any rescue medication after NA cessation in 206882 | From Month 3 up to Month 57 |
| Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have clinical relapse or use of any rescue medication after NA cessation in 206882 | From Month 3 up to Month 57 |
| Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882 and have use of any rescue medication after NA cessation in 206882 | From Month 3 up to Month 57 |
| Percentage of participants with anti-HBs (antibody to HBsAg) | Up to 57 months |
| Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg]) | Up to 57 months |
| Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL]) | Up to 57 months |
| Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL) | Baseline (End of Study visit in the parent study) and up to 57 months |
| Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL]) | Up to 57 months |
| Change from Baseline for HBcrAg (kU/mL) | Baseline (End of Study visit in the parent study) and up to 57 months |
| Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml) | Up to 57 months |
| Change from Baseline for HBV RNA (log10 IU/ml) | Baseline (End of Study visit in the parent study) and up to 57 months |
| Percentage of participants with mutations | Up to 57 months |
| San Jose |
| California |
| 95128 |
| United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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