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Virus Therapy

Bulevirtide for Kidney Function

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

All Individuals: No known Liver Disease (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) ≤ 3 x upper limit of normal (ULN) at screening

Must not have

Individuals with RI: Individuals requiring or anticipated to require dialysis within 90 days of study entry

Individuals with RI: 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: predose up to 24 hours postdose and day 6: predose up to 48 hours postdose

Awards & highlights

Summary

This trial will compare the effects of a study drug on bile acids, measure how much gets into the bloodstream, and check safety/tolerability in people with normal/impaired kidney function.

Who is the study for?

This trial is for people with normal or impaired kidney function who need treatment for Hepatitis D. They should have a stable BMI, no serious liver issues, and a stable heart condition if they have one. People can't join if they've used certain drugs recently, have HIV/HBsAg/HCV, are expected to need dialysis soon, or have uncontrolled blood pressure.

What is being tested?

The study tests Bulevirtide (BLV) in participants with different levels of kidney health. It looks at how much BLV gets into the blood, its effect on bile acids, and how long it stays in the body. The safety of multiple doses will also be evaluated.

What are the potential side effects?

While specific side effects aren't listed here, the trial will monitor how safe and tolerable Bulevirtide is when given in multiple doses to individuals with varying degrees of kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, with an eGFR of 90 or higher.

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My liver tests are within normal limits.

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My hemoglobin level is 9 g/dL or higher and I have kidney problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might need dialysis within the next 3 months.

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I haven't taken any kidney-damaging drugs in the last 28 days.

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I have taken medication or herbal products, except vitamins, in the last 28 days.

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I have tested positive for HIV, hepatitis B, or hepatitis C.

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I have very high or very low blood pressure that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: predose up to 24 hours postdose and day 6: predose up to 48 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: predose up to 24 hours postdose and day 6: predose up to 48 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose up to 24 hours postdose and day 6: predose up to 48 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK Parameter: Cmax ss of BLV

Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)

Secondary study objectives

PK Parameter: AUC0-24 of BLV

PK Parameter: AUC0-24 of Total BA

PK Parameter: CLss/F of BLV

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group A: Bulevirtide (BLV), Severe Renal Impaired ParticipantsExperimental Treatment1 Intervention

Participants with severe renal impairment will receive BLV 2 mg once daily for 6 days. Following completion and evaluation of pharmacokinetics (PK) and safety data from all participants in Group A, additional participant groups (Groups B, C, and D) and BLV doses (2 mg or 10 mg) may be initiated.

Group II: Group A: BLV, Normal Renal Function (Matched Control Participants)Experimental Treatment1 Intervention

Participants with normal renal function will receive BLV 2 mg once daily for 6 days. Following completion and evaluation of PK and safety data from all participants in Group A, additional participant groups (Groups B, C, and D) and BLV doses (2 mg or 10 mg) may be initiated.

0 / 8Eligibility criteria met