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Chronic Hepatitis D InfectionPhase 1NCT05760300

A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function

A Phase 1 study testing Bulevirtide (BLV) in people with Chronic Hepatitis D Infection, run by Gilead Sciences at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis D Infection
What is being tested?
Bulevirtide (BLV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
9 sitesUnited States
Study dates
15 Mar 2023to 23 Jul 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Individuals:
  • Body mass index (BMI) of at least ≥ 18.0 kg/m^2 and ≤ 40.0 kg/m^2 at screening.
  • No clinically significant abnormalities on electrocardiogram (ECG)
  • No known Liver Disease (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) ≤ 3 x upper limit of normal (ULN) at screening.
  • Individuals with Renal Impairment (RI):
  • Have RI classification at screening that has been unchanged during the 90 days prior to study drug dosing.
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  • Estimated Glomerular Filtration Rate (eGFR) must be the following (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Inker 2021)) based on serum creatinine as measured at the screening evaluation:
  • Severe RI (Groups A and B): eGFR ≥ 15 to ≤ 29 mL/min/1.73 m^2
  • Moderate RI (Group C): eGFR ≥ 30 to ≤ 59 mL/min/1.73 m^2
  • Mild RI (Group D): eGFR ≥ 60 to ≤ 89 mL/min/1.73 m^2
  • Hemoglobin ≥ 9 g/dL at screening.
  • Individuals with cardiovascular disease, hypertension, diabetes mellitus, hyperlipidemia, hypothyroidism, osteoporosis, and many others) may be included provided that these diseases/conditions are clinically stable.
  • Matched Control Individuals:
  • Have an eGFR of at least 90 mL/min/1.73 m^2 (using the CKD-EPI equation) based on serum creatinine as measured at screening evaluation.
  • Matched for sex, age (± 10 years), and BMI (± 20%, 18.0 ≤ BMI ≤ 40.0 kg/m^2) with the respective participant in the RI group.

Who cannot join

  • All Individuals:
  • Positive human immunodeficiency virus (HIV) test, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody with detectable HCV viral ribonucleic acid (RNA) at screening.
  • Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with participant treatment, assessment, or compliance with the protocol.
  • Individuals with RI:
  • Recent history of reception of any blood or blood products or history of major bleeding within 4 weeks of dosing.
  • Positive test for drugs of abuse, including alcohol at screening or admission, with the exception of opioids and tetrahydrocannabinol (THC, marijuana) under prescription and verified by the investigator as for pain management.
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  • Received treatment with trimethoprim or cimetidine or tenofovir prodrugs (tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF)) (affects elimination of creatinine) or with competitors of renal tubular excretion (eg, probenecid, chronic high-dose nonsteroidal anti-inflammatory drugs) within 28 days of Day -1.
  • Received known nephrotoxic drugs (eg, aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, cyclosporine, tacrolimus, herbal remedies (eg, compounds with aristolochic acid)) within 28 days of Day -1.
  • Individuals requiring or anticipated to require dialysis within 90 days of study entry.
  • Serum albumin concentration <25 g/L.
  • Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
  • Matched Control Individuals:
  • Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Massachusetts General Hospital - Renal Associates Clinic

    Boston, Massachusetts, 02114

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida, 32132

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida, 33016

  • Nucleus Network

    Saint Paul, Minnesota, 55114

  • Global Clinical Professionals Research

    St. Petersburg, Florida, 33705

  • Genesis Clinical Research, LLC

    Tampa, Florida, 33603

Other trials in United States

About this study

Official title: A Phase 1 Open-Label, Parallel-Design, Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide in Participants With Normal and Impaired Renal Function

The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.

Being tested
Bulevirtide (BLV)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bulevirtide (BLV)Drug

    Also called Hepcludex®, Myrcludex B

    Administered via subcutaneous (SC) injections

Study groups in NCT05760300
Study groupRoleWhat they receive
Group A: BLV 2 mg (Severe RI Group)ExperimentalParticipants with severe renal impairment (RI) [estimated glomerular filtration rate (eGFR) ≥ 15 to ≤ 29 mL/min/1.73 m^2] will receive bulevirtide (BLV) 2 mg, administered subcutaneously (SC), once daily (QD), for 6 days.
Receives: Drug: Bulevirtide (BLV)
Group A: BLV 2 mg (Matched Control)ExperimentalParticipants with normal renal function (matched control group) [eGFR ≥ 90 mL/min/1.73 m^2] will receive BLV 2 mg, administered SC, QD, for 6 days.
Receives: Drug: Bulevirtide (BLV)
Group B: BLV 10 mg (Severe RI Group)ExperimentalParticipants with severe RI [eGFR ≥ 15 to ≤ 29 mL/min/1.73 m^2] will receive BLV 10 mg, administered SC, QD, for 6 days.
Receives: Drug: Bulevirtide (BLV)
Group B: BLV 10 mg (Matched Control)ExperimentalParticipants with normal renal function (matched control group) [eGFR ≥ 90 mL/min/1.73 m^2] will receive BLV 10 mg, administered SC, QD, for 6 days.
Receives: Drug: Bulevirtide (BLV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) Parameter for Bulevirtide (BLV): AUCtau

    AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state at Day 6.

    Measured: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose

  2. PK Parameter for BLV: Cmax ss

    Cmax is defined as the maximum observed concentration of drug at steady state at Day 6.

    Measured: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose

Secondary outcomes (11)

  1. PK Parameter for BLV: AUC0-24

    AUC0-24 is defined as the concentration of drug over time between time 0 hour and time 24 hours.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose

  2. PK Parameter for BLV: Cmax

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose

  3. PK Parameter for BLV: Tmax

    Tmax is defined as the time (observed time point) of Cmax.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  4. PK Parameter for BLV: t1/2

    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  5. PK Parameter for BLV: CLss/F

    CLss/F is defined as the apparent clearance at steady state at Day 6. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug per interval.

    Measured: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  6. PK Parameter for BLV: Vss/F

    Vss/F is defined as the apparent volume of distribution at steady state at Day 6.

    Measured: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  7. Pharmacodynamic (PD) Parameter for Total Bile Acids (BA): Cmax

    The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. Cmax is defined as the maximum observed concentration of total BA. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  8. PD Parameter for Total BA: AUC0-24

    The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. AUC0-24 is defined as the concentration of total BA over time between time 0 hour and time 24 hours. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.

    Measured: Days 1 and 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose

  9. PD Parameter for Total BA: NetAUC

    The PD effect of BLV was evaluated on plasma BA in participants with RI compared to matched control participants with normal renal function. NetAUC is defined as positive portion of area under the baseline-adjusted biomarker concentration versus time curve over the dosing interval. The plasma bile acid panel includes 15 individual bile acids, and total BA is the sum of these 15 components.

    Measured: Day 1: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose; Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, and 48 hours postdose

  10. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or if the AE onset date was the same as the date of study drug start date then the AE onset time must have been on or after the study drug start time. If the AE onset time was missing when the start dates was the same, the AE was considered treatment emergent.and/or any AEs leading to premature discontinuation of study drug.

    Measured: Up to 36 days

  11. Percentage of Participants Experiencing Laboratory Abnormalities

    A treatment-emergent laboratory abnormality was any value that was outside the reference range at any time post baseline up to and including the date of last study drug dose plus 30 days. Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death. Participants with at least a 1 grade increased from baseline for an individual laboratory test where the maximum post baseline laboratory abnormality was grade 1 or higher and grade 3 or higher were reported. The maximum post baseline toxicity grade across all tests for an individual participant was used in analysis.

    Measured: Up to 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start15 Mar 2023
  3. Primary completion18 Jul 2024
  4. Study completion23 Jul 2024

Resources

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05760300
Sponsor's protocol ID
GS-US-589-6160
Other IDs
2022-502054-13-00
Status last verified
Aug 2025
First submitted
27 Feb 2023
Last updated
18 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yehong Wang, Renee-Claude Mercier, Wildaliz Nieves, David Pan, Carrie Nielson, SteveTseng, Xu Zhang, Ann Qin, Parag Kumar. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 2 mg Once Daily for 6 Days in Participants with Severe Renal Impairment and in Matched Control Participants with Normal Renal Function. The Liver Meeting, American Association for the Study of Liver Diseases; November 15-19, 2024; San Diego, CA. Abstract #1194.

  • Yehong Wang, Renee-Claude Mercier, Wildaliz Nieves, Carolina Machado, Steve Tseng, Yuejiao Jiang, Ann Qin, Teckla Akinyi, Parag Kumar, WED-313 Pharmacokinetics, pharmacodynamics, and safety of bulevirtide 10 mg once daily for 6 days in participants with severe renal impairment and in matched control participants with normal renal function, Journal of Hepatology, Volume 82, Supplement 1, 2025, Page S824 (https://doi.org/10.1016/S0168-8278(25)02119-1).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bulevirtide (BLV) in people with Chronic Hepatitis D Infection, run by Gilead Sciences at 9 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetic (PK) Parameter for Bulevirtide (BLV): AUCtau (time frame: Day 6: Predose (≤ 30 minutes before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose). 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?

On the ClinicalTrials.gov record for NCT05760300, which also lists 2 linked publications.

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 18 Sep 2025.

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