Bulevirtide for Kidney Function

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) must be between 18.0 and 40.0 at the screening.

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

My liver tests are within normal limits.

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Exclusion Criteria

I might need dialysis within the next 3 months.

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

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

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Treatment Details

Interventions

Bulevirtide (BLV) (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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.