Kidney function may affect hepatitis b drug levels
NCT ID NCT07168356
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study gives a single dose of bepirovirsen to 32 adults with hepatitis B, some with kidney disease and some healthy. Researchers measure how much drug gets into the blood and how long it stays. The goal is to see if kidney problems change drug levels, which could affect future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bepirovirsen
- What this could lead to
- If successful, this study could help doctors determine the right dose of bepirovirsen for hepatitis B patients with kidney problems.
- What could go wrong
- This is a very early, small study (32 people) focused on drug levels, not on treating hepatitis B. It may not lead to any treatment changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Sep 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 80 years, inclusive * Body weight greater than or equal to 50 kilograms (kg) and body mass index (BMI) within the range 19 to 40 kilograms per square meter (kg/m\^2). * Males and females may participate. Female participants must not be pregnant or breastfeeding, and must be of non-childbearing potential, or agree to use a highly effective method of contraception. * Capable of giving signed informed consent Additional inclusion criteria for renal impairment groups (Group 1 and Group 2) * Severe renal impairment \[estimated glomerular filtration rate (eGFR) adjusted for actual body surface area (BSA) less than 30 milliliters per minute (ml/min); Group 1\] or moderate renal impairment \[eGFR adjusted for actual BSA between 30 and 59 ml/min; Group 2\], from any cause other than vasculitis or glomerulonephritis Additional inclusion criteria for healthy control participants with normal renal function (Group 3) * Healthy, based on medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG). * Normal renal function (eGFR adjusted for actual BSA greater than or equal to 90 ml/min) Exclusion Criteria: * Any medical condition that could affect the absorption, metabolism, or elimination of drugs, increase the risk of taking part in the study, or interfere with interpretation of the study data. * History of vasculitis or any type of glomerulonephritis * Use of creatine-containing supplements within 30 days of screening or intended use during the study. * Current enrolment in another interventional study, or past participation in a study where an investigational medicine, vaccine or device was administered if, at the time of consent, it is within 5 half-lives or twice the duration of the biological effect (whichever is longer) of the product given in the previous study. * Received any oligonucleotide or small interfering ribonucleic acid (siRNA) within the past 12 months. * Exposure to more than 4 investigational products within the past 12 months. * A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). * Average weekly alcohol intake of greater than 14 drinks for males or greater than 7 drinks for females. * Current substance misuse or dependence, or a previous history of substance misuse or dependence that could interfere with ability to participate in the study. Additional exclusion criteria for renal impairment groups (Group 1 and Group 2) * History of renal transplantation or anticipated renal transplant during the study. * On dialysis or likely to require dialysis during the study. * Positive drug or alcohol screen (unless because of prescribed medication). Additional exclusion criterion for healthy control group (Group 3) * Positive drug or alcohol screen. * Urine albumin-to-creatinine ratio (uACR) \> 0.3 mg/mg (300 mg/g).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Orlando, Florida, 32809, United States
-
GSK Investigational Site
Tampa, Florida, 33603, United States
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GSK Investigational Site
San Antonio, Texas, 78215, United States
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