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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
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: AUC0-24 of BLV
PK Parameter: AUC0-24 of Total BA
PK Parameter: CLss/F of BLV
+9 moreTrial 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.
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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
1,084 Previous Clinical Trials
848,399 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,613 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I might need dialysis within the next 3 months.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.Your heart's ECG test should not show any significant abnormalities.I match in sex, age (± 10 years), and BMI (± 20%, within 18.0-40.0) with a study participant.My hemoglobin level is 9 g/dL or higher and I have kidney problems.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.Your blood has low levels of a protein called albumin.I haven't taken specific drugs that affect kidney function in the last 28 days.I have tested positive for HIV, hepatitis B, or hepatitis C.I haven't received blood products or had major bleeding in the last 4 weeks.My kidney function has been stable for the last 3 months.I tested positive for drugs or alcohol, but my opioids or THC use is prescribed for pain.I have very high or very low blood pressure that is not well-controlled.I have stable health conditions alongside my kidney issues.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Bulevirtide (BLV), Severe Renal Impaired Participants
- Group 2: Group A: BLV, Normal Renal Function (Matched Control Participants)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially join this clinical experiment?
"Eligibility for this trial requires that candidates are between 18 and 79 years old, as well as have a chronic hepatitis d diagnosis. Currently, 80 individuals are being recruited to partake in the study."
Answered by AI
Are participants who are youthful than 70 years old qualified to participate in this trial?
"To be eligible for this research, participants must fulfill the age criteria of 18 to 79 years. There are 6 trials that cater exclusively to those under 18 and 168 specifically designed for patients over 65."
Answered by AI
Is there any vacancy for participants in the trial?
"The evidence accessible on clinicaltrials.gov suggests that this medical trial is no longer recruiting patients, although it was initially posted on March 1st 2023 and edited for the last time 24 days later. However, at present there are 175 other studies actively looking for volunteers to participate in them."
Answered by AI
Is Group A: BLV, Normal Renal Function (Matched Control Participants) safe for human consumption?
"Our team at Power analyses the safety of Group A: BLV, Normal Renal Function (Matched Control Participants) to be a 1 due to its phase 1 status. This is because there is limited data on both efficacy and safety."
Answered by AI
Who else is applying?
What site did they apply to?
Velocity Clinical Research, New Smyrna Beach
What portion of applicants met pre-screening criteria?
Met criteria
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