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Virus Therapy

Bulevirtide for Hepatitis D

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
All individuals must have a calculated creatinine clearance (CLcr) of at least 60 mL/min based on serum creatinine and actual body weight as measured at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose and up to 24 hours postdose; day 6: predose and up to 48 hours postdose
Awards & highlights

Study Summary

This trial looks at how a drug, bulevirtide, affects bile acids and how safe it is in people with normal or impaired liver function.

Who is the study for?
This trial is for individuals with chronic Hepatitis D, who are healthy enough as per medical evaluation, have a BMI between 19-40 kg/m^2, and kidney function above a certain level. They must agree to use contraception if applicable and not donate blood during the study. People with recent drug treatments or substance abuse issues, significant allergies or serious health conditions cannot participate.Check my eligibility
What is being tested?
The study tests Bulevirtide in people with varying liver functions. It measures how much of the drug enters the bloodstream, its elimination rate, impact on bile acids, and assesses safety over multiple doses.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally this type of study will monitor for any adverse reactions including but not limited to digestive issues, allergic responses or changes in vital signs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameter: Cmax,ss of BLV
Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
Secondary outcome measures
PK Parameter: AUC0-24h of BLV
PK Parameter: AUC0-24h of Total BA
PK Parameter: CLss/F of BLV
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Bulevirtide (BLV), Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive BLV 2 mg injection once daily for 6 days starting on Day 1. Following completion and evaluation of pharmacokinetics (PK) and safety data, additional participant groups and BLV doses may be initiated.
Group II: BLV, Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment will receive BLV 2 mg injection once daily for 6 days starting on Day 1. Following completion and evaluation of PK and safety data, additional participant groups and BLV doses may be initiated.
Group III: BLV, Normal Hepatic Function (Matched Control Participants)Experimental Treatment1 Intervention
Participants with normal hepatic function will receive BLV 2 mg once daily for 6 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bulevirtide
2019
Completed Phase 2
~230

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,079 Previous Clinical Trials
836,987 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
342 Previous Clinical Trials
186,250 Total Patients Enrolled

Media Library

Bulevirtide (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05765344 — Phase 1
Chronic Hepatitis D Research Study Groups: BLV, Normal Hepatic Function (Matched Control Participants), BLV, Severe Hepatic Impairment, Bulevirtide (BLV), Moderate Hepatic Impairment
Chronic Hepatitis D Clinical Trial 2023: Bulevirtide Highlights & Side Effects. Trial Name: NCT05765344 — Phase 1
Bulevirtide (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765344 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial have a lower age limit for participants?

"This clinical trial adheres to the following age parameters for participant eligibility: 18 years old at a minimum and 79 years old at a maximum."

Answered by AI

To what demographic is enrollment in this research endeavor open?

"Requirements for admittance into this clinical trial dictate that applicants must have chronic hepatitis D and fall between the ages of 18 to 79. The study is aiming to recruit approximately 72 individuals."

Answered by AI

Has the FDA sanctioned Bulevirtide (BLV) for Moderate Hepatic Impairment?

"Bulevirtide's Moderate Hepatic Impairment safety rating is assessed as 1 due to limited clinical data supporting both its efficacy and safety, commensurate with it being in Phase 1 of trialing."

Answered by AI

Is recruitment for this research project still open?

"Affirmative, clinicaltrials.gov alludes to the fact that this research project is presently recruiting participants. It was first launched on March 15th 2023 and since then has been amended most recently on March 30th 2023. To date, 72 patients are needed from one trial hub."

Answered by AI

What is the ceiling of enrollees in this investigation?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking participants since it was initially posted on March 15th of 2023 and finally modified on the 30th day of the same month. It requires 72 volunteers from one centre for completion."

Answered by AI
~33 spots leftby Feb 2025