Pevifoscorvir Sodium for Chronic Hepatitis B
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called pevifoscorvir sodium for individuals with chronic hepatitis B. Researchers aim to evaluate how this drug affects people with varying levels of kidney function, including those with and without kidney issues. Participants will receive a single dose and undergo monitoring for two weeks. This trial may suit adults with chronic hepatitis B who have stable kidney problems or no kidney issues. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive it.
Do I have to stop taking my current medications for the trial?
The trial requires that your current medications for managing your medical history be stable for at least 28 days before screening. It doesn't specify stopping other medications, so you should discuss your specific situation with the trial team.
Is there any evidence suggesting that pevifoscorvir sodium is likely to be safe for humans?
Research has shown that pevifoscorvir sodium, also known as ALG-000184, was well-tolerated in previous studies. Participants who took either single or multiple daily doses experienced good safety outcomes. No serious side effects occurred, and the drug was safe at various dose levels. These findings suggest that pevifoscorvir sodium is generally safe for people. However, this trial remains in the early stages, focusing on safety. Further studies will help confirm these results.12345
Why do researchers think this study treatment might be promising?
Pevifoscorvir Sodium is unique because it targets chronic Hepatitis B with a potentially new approach. Unlike most treatments, which often involve nucleos(t)ide analogs like tenofovir or entecavir that suppress the virus over long periods, pevifoscorvir sodium may offer a different mechanism of action. Researchers are excited about this drug because it could provide a more efficient and possibly shorter treatment option, which might lead to better patient adherence and outcomes. Additionally, its single-dose administration could simplify treatment regimens, making it easier for patients to manage their condition.
What evidence suggests that pevifoscorvir sodium might be an effective treatment for chronic hepatitis B?
Research has shown that pevifoscorvir sodium may help treat chronic hepatitis B by lowering the virus levels in the body, potentially leading to better health. Studies found it effective for up to 96 weeks, indicating long-lasting benefits. Early results also suggest that pevifoscorvir sodium is safe and well-tolerated by patients. These findings are promising for those considering joining a clinical trial, where participants will receive single oral doses of 100 mg pevifoscorvir sodium, either with or without renal impairment.34678
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
Citations
1.
biospace.com
biospace.com/press-releases/aligos-therapeutics-provides-phase-2-b-supreme-study-progress-updatesAligos Therapeutics Provides Phase 2 B-SUPREME Study ...
Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with ...
Articles ALG-000184 (pevifoscorvir sodium) monotherapy ...
ALG-000184 was safe and well tolerated, demonstrated predictable pharmacokinetic properties, and reduced HBV DNA and HBV RNA at all doses ...
ALG-000184 (pevifoscorvir sodium) monotherapy in ...
ALG-000184 was safe and well tolerated, demonstrated predictable pharmacokinetic properties, and reduced HBV DNA and HBV RNA at all doses ...
Pevifoscorvir Sodium's Promising Outcomes from AASLD ...
Late-breaking AASLD 2025 data show that pevifoscorvir sodium produced sustained antiviral activity at 96 weeks in chronic hepatitis B. The ...
Phase 2 B-SUPREME Study Progress by Aligos - ALGS
In longer term Phase 1 studies, pevifoscorvir sodium 300mg QD x ≤96 weeks monotherapy has demonstrated sustained reductions in HBV DNA, RNA, ...
A Phase 1 study of the safety, tolerability, and ...
The pharmacokinetic profile suggests that a daily dose of 100 mg or higher will provide efficacious exposures in patients with chronic HBV ...
7.
investor.aligos.com
investor.aligos.com/news-releases/news-release-details/aligos-therapeutics-provides-phase-2-b-supreme-study-progressAligos Therapeutics Provides Phase 2 B-SUPREME Study ...
Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with ...
NCT07342881 | Single Dose Study to Evaluate the ...
Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium ... Chronic Hepatitis B Infection. Additional Relevant ...
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