Pevifoscorvir Sodium for Chronic Hepatitis B
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with varying degrees of renal impairment or normal kidney function, matched by age, weight, and sex. Participants must be in good health aside from their kidney issues and have stable medications for at least 28 days prior. Women of childbearing potential must use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 100 mg pevifoscorvir sodium
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pevifoscorvir Sodium (ALG-000184)
Trial Overview
The study tests Pevifoscorvir Sodium (ALG-000184) in participants with severe to no renal impairment. It's a Phase 1 non-randomized, open-label trial where subjects receive a single dose to assess how the drug behaves in the body and its safety profile.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects without renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.
Subjects with renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aligos Therapeutics
Lead Sponsor
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