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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have liver issues but meet specific health criteria and have been on stable medication for 4 weeks.I do not have issues with blood draws due to poor vein access.I have normal liver function, no HIV, hepatitis B or C, and no history of liver disease.I have liver issues but tested negative for HIV, hepatitis B, and C.I am generally healthy apart from liver issues, as confirmed by my doctor's exams and tests.My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.I do not have serious skin, heart issues, severe ulcers, major mental illness, or need for forbidden meds.I don't have liver cancer, won't change my medications soon, don't use liver-damaging drugs, and don't use recreational drugs.My liver condition has been stable for the last 2 months.
- Group 1: BLV, Normal Hepatic Function (Matched Control Participants)
- Group 2: BLV, Severe Hepatic Impairment
- Group 3: Bulevirtide (BLV), Moderate Hepatic Impairment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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