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NCT07168356Active, not recruitingPhase 1

A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease

A Phase 1, Open-Label, Single-Dose, Parallel Group, 2-Part Study to Evaluate the Pharmacokinetics of Bepirovirsen in Adult Participants With Severe or Moderate Renal Impairment Compared to Matched Healthy Control Participants

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
32 (actual)
First submitted
10 Sept 2025
Start date
26 Sept 2025
Primary completion date
3 Mar 2026
Lead sponsor
GlaxoSmithKline
Diseases
Hepatitis B
NCT number
NCT07168356

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 32
  • From 26 Sept 2025 to the primary completion date, 3 Mar 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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)
  • Positive drug or alcohol screen (unless because of prescribed medication). Additional exclusion criterion for healthy control group (Group 3)
  • Positive drug or alcohol screen.

Other illness

  • 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
  • A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  • History of renal transplantation or anticipated renal transplant during the study.

Lab values

  • Urine albumin-to-creatinine ratio (uACR) \> 0.3 mg/mg (300 mg/g).

Other

  • Use of creatine-containing supplements within 30 days of screening or intended use during the study.
  • Average weekly alcohol intake of greater than 14 drinks for males or greater than 7 drinks for females.
  • On dialysis or likely to require dialysis during the study.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GSK Investigational Site
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.