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

NCT ID: NCT05760300

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-07-23

Brief 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 (kidney) function.

Conditions

Chronic Hepatitis D Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: BLV 2 mg (Severe RI Group)

Participants 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.

Group Type: EXPERIMENTAL

Bulevirtide (BLV)

Intervention Type: DRUG

Administered via subcutaneous (SC) injections

Group A: BLV 2 mg (Matched Control)

Participants 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.

Group Type: EXPERIMENTAL

Bulevirtide (BLV)

Intervention Type: DRUG

Administered via subcutaneous (SC) injections

Group B: BLV 10 mg (Severe RI Group)

Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] will receive BLV 10 mg, administered SC, QD, for 6 days.

Group Type: EXPERIMENTAL

Bulevirtide (BLV)

Intervention Type: DRUG

Administered via subcutaneous (SC) injections

Group B: BLV 10 mg (Matched Control)

Participants 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.

Group Type: EXPERIMENTAL

Bulevirtide (BLV)

Intervention Type: DRUG

Administered via subcutaneous (SC) injections

Interventions

Bulevirtide (BLV)

Administered via subcutaneous (SC) injections

Intervention Type: DRUG

Other Intervention Names

Hepcludex®; Myrcludex B

Eligibility Criteria

Inclusion Criteria

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.
• 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.

Exclusion Criteria

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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, United States

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Advanced Pharma CR, LLC

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Global Clinical Professionals Research

St. Petersburg, Florida, United States

Genesis Clinical Research, LLC

Tampa, Florida, United States

Massachusetts General Hospital - Renal Associates Clinic

Boston, Massachusetts, United States

Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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).

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study?nctid=NCT05760300

Gilead Clinical Trials Website

Other Identifiers

2022-502054-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-589-6160

Identifier Type: -

Identifier Source: org_study_id