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This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Severe Renal Impairment Participants | Experimental | Participants with severe renal impairment will receive Bepirovirsen. |
|
| Group 2- Moderate Renal Impairment Participants | Experimental | Participants with moderate renal impairment will receive Bepirovirsen. |
|
| Group 3-Healthy Control Participants | Experimental | Healthy control participants will receive Bepirovirsen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepirovirsen | Drug | Bepirovirsen will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen | Up to Day 50 | |
| Maximum Observed Concentration (Cmax) of Bepirovirsen | Up to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen | Up to 24 hours | |
| Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 168 hours (Day 8) [AUC(0-168)] of Bepirovirsen |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for renal impairment groups (Group 1 and Group 2)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Orlando | Florida | 32809 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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This is an open-label study.
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| Up to 168 hours |
| Observed Concentration of Bepirovirsen on Day 8 | At Day 8 |
| Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen | Up to Day 50 |
| Apparent Clearance (CL/F) of Bepirovirsen | Up to Day 50 |
| Time of Occurrence of Cmax (Tmax) of Bepirovirsen | Up to Day 50 |
| Apparent Terminal Phase Volume of Distribution (Vz/F) of Bepirovirsen | Up to Day 50 |
| Tampa |
| Florida |
| 33603 |
| United States |
| GSK Investigational Site | San Antonio | Texas | 78215 | United States |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |