Group A: Bulevirtide (BLV), Severe Renal Impaired Participants for Chronic Hepatitis D

Clinical Pharmacology of Miami, LLC, Miami, FL
Chronic Hepatitis D+1 More ConditionsBulevirtide (BLV) - Drug
Eligibility
18 - 79
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Chronic Hepatitis D
  • Chronic Hepatitis Delta Infection

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Day 1: Predose up to 24 hours postdose and Day 6: Predose up to 48 hours postdose

Day 6
PK Parameter: AUC0-24 of Total BA
PK Parameter: Cmax of Total BA
PK Parameter: Tmax of BLV
PK Parameter: Tmax of Total BA
Day 1
PK Parameter: AUC0-24 of BLV
PK Parameter: Cmax of BLV
Day 6
PK Parameter: t1/2 of BLV
Day 8
PK Parameter: Ctrough of Total Bile Acids (BA)
Day 6
PK Parameter: Cmax ss of BLV
Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
Day 6
PK Parameter: CLss/F of BLV
PK Parameter: Vss/F of BLV
Day 7
Percentage of Participants With Laboratory Abnormalities
Percentage of Participants With Treatment-Emergent Adverse Events

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group A: Bulevirtide (BLV), Severe Renal Impaired Participants
1 of 2
Group A: BLV, Normal Renal Function (Matched Control Participants)
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Group A: Bulevirtide (BLV), Severe Renal Impaired Participants · No Placebo Group · Phase 1

Group A: Bulevirtide (BLV), Severe Renal Impaired Participants
Drug
Experimental Group · 1 Intervention: Bulevirtide (BLV) · Intervention Types: Drug
Group A: BLV, Normal Renal Function (Matched Control Participants)
Drug
Experimental Group · 1 Intervention: Bulevirtide (BLV) · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1: predose up to 24 hours postdose and day 6: predose up to 48 hours postdose

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,037 Previous Clinical Trials
776,210 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
331 Previous Clinical Trials
184,911 Total Patients Enrolled

Eligibility Criteria

Age 18 - 79 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.