Hepatitis BPhase 1B-KindNCT07168356
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Bepirovirsen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Sep 2025to 18 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
San Antonio, Texas, 78215
GSK Investigational Site
Tampa, Florida, 33603
About this study
Official title: 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
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.
- Conditions
- Hepatitis B
- Being tested
- Bepirovirsen
- Keywords
- Bepirovirsen, Pharmacokinetics, Severe renal impairment, Moderate renal impairment, Healthy participants, Renal function, Kidney disease, Hepatitis B
- Medical subject headings
- Hepatitis B, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepirovirsenDrug
Bepirovirsen will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Severe Renal Impairment Participants | Experimental | Participants with severe renal impairment will receive Bepirovirsen. Receives: Drug: Bepirovirsen |
| Group 2- Moderate Renal Impairment Participants | Experimental | Participants with moderate renal impairment will receive Bepirovirsen. Receives: Drug: Bepirovirsen |
| Group 3-Healthy Control Participants | Experimental | Healthy control participants will receive Bepirovirsen. Receives: Drug: Bepirovirsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
Measured: Up to Day 50
Maximum Observed Concentration (Cmax) of Bepirovirsen
Measured: Up to Day 50
Secondary outcomes (7)
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen
Measured: 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
Measured: Up to 168 hours
Observed Concentration of Bepirovirsen on Day 8
Measured: At Day 8
Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen
Measured: Up to Day 50
Apparent Clearance (CL/F) of Bepirovirsen
Measured: Up to Day 50
Time of Occurrence of Cmax (Tmax) of Bepirovirsen
Measured: Up to Day 50
Apparent Terminal Phase Volume of Distribution (Vz/F) of Bepirovirsen
Measured: Up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start26 Sep 2025
- Primary completion3 Mar 2026
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168356
- Sponsor's protocol ID
- 205872
- Acronym
- B-Kind
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07168356
- Acronym / sponsor ID
- B-Kind / 205872
- Conditions
- Hepatitis B
- Keywords
- Bepirovirsen, Pharmacokinetics, Severe renal impairment, Moderate renal impairment, Healthy participants, Renal function, Kidney disease, Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- Severe Renal Impairment Participants | Experimental | Drug: BepirovirsenParticipants with severe renal impairment will receive Bepirovirsen. |
| Group 2- Moderate Renal Impairment Participants | Experimental | Drug: BepirovirsenParticipants with moderate renal impairment will receive Bepirovirsen. |
| Group 3-Healthy Control Participants | Experimental | Drug: BepirovirsenHealthy control participants will receive Bepirovirsen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BepirovirsenBepirovirsen will be administered. | Drug | Group 1- Severe Renal Impairment Participants, Group 2- Moderate Renal Impairment Participants, Group 3-Healthy Control Participants |
Primary outcome
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
Time frame: Up to Day 50
Maximum Observed Concentration (Cmax) of Bepirovirsen
Time frame: Up to Day 50
7 secondary outcomes
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen
Time frame: 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
Time frame: Up to 168 hours
Observed Concentration of Bepirovirsen on Day 8
Time frame: At Day 8
Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen
Time frame: Up to Day 50
Apparent Clearance (CL/F) of Bepirovirsen
Time frame: Up to Day 50
Time of Occurrence of Cmax (Tmax) of Bepirovirsen
Time frame: Up to Day 50
Apparent Terminal Phase Volume of Distribution (Vz/F) of Bepirovirsen
Time frame: Up to Day 50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen (time frame: Up to Day 50). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.