Pevifoscorvir Sodium for Liver Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called pevifoscorvir sodium (ALG-000184) for individuals with liver problems. Researchers aim to observe how the drug behaves in the body when taken by people with moderate liver impairment compared to those without liver issues. Participants in one group have stable liver issues due to long-term liver disease, while the other group has no liver problems. The trial seeks to gather information that could improve treatment options for liver conditions. Individuals with stable liver disease for at least three months or those without liver issues might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Is there any evidence suggesting that pevifoscorvir sodium is likely to be safe for humans?
Research has shown that pevifoscorvir sodium has promising safety results from earlier studies. In one study, healthy participants tolerated pevifoscorvir sodium well, experiencing no serious side effects. The medicine appeared safe and did not cause major problems.
While this trial is still in its early stages, previous testing in humans suggested the treatment is generally safe. Participants reported few negative side effects, providing some confidence that the treatment is well-tolerated. However, it's important to remember that early trials focus on safety, so new information may emerge as more people participate.12345Why do researchers think this study treatment might be promising?
Pevifoscorvir Sodium is unique because it offers a potential new approach to treating liver impairment by using its novel active ingredient, ALG-000184. Unlike standard treatments, such as antiviral medications or lifestyle changes that focus mainly on managing symptoms and preventing progression, Pevifoscorvir Sodium directly targets the virus involved in liver damage. Researchers are excited about this treatment because it could provide a more direct and potentially faster way to address the root cause of liver impairment, improving patient outcomes.
What evidence suggests that pevifoscorvir sodium might be an effective treatment for liver impairment?
Research has shown that pevifoscorvir sodium is generally safe and well-tolerated. Participants in previous studies took doses up to 300 mg for extended periods without liver harm. This trial will evaluate pevifoscorvir sodium in two groups: subjects with hepatic impairment and those without, both receiving single oral doses of 100 mg. The drug targets the virus's protective shell, potentially stopping the virus from multiplying. Early results indicate that the body absorbs and processes the drug well. These encouraging findings suggest that pevifoscorvir sodium could effectively treat liver-related conditions.12346
Are You a Good Fit for This Trial?
This trial is for adults with moderate liver problems (hepatic impairment) and healthy adults with normal liver function. They should match in age, weight, and possibly sex. People can't join if they have other significant health issues or conditions that could interfere with the drug's effects or their participation.Inclusion Criteria
Exclusion 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 how a single dose of Pevifoscorvir Sodium (ALG-000184), a potential Hepatitis B treatment, behaves in the body and its safety profile. It compares people with moderate liver problems to those without any liver issues.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects without hepatic 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 hepatic 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
NCT07342868 | Single-Dose Study to Evaluate the ...
The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir ...
ALG-000184 (pevifoscorvir sodium) monotherapy in ...
In all cases, there were no changes in markers of hepatic function suggestive of drug-induced liver injury. Although many participants had ...
3.
investor.aligos.com
investor.aligos.com/news-releases/news-release-details/aligos-therapeutics-presents-positive-data-liver-meetingr-2025Aligos Therapeutics Presents Positive Data at The Liver ...
A favorable tolerability profile was observed in both HBeAg+ and HBeAg- subjects receiving 300 mg pevifoscorvir sodium for up to 96 weeks. “We ...
A Phase 1 study of the safety, tolerability, and ...
ALG-000184 demonstrated good tolerability, safety and pharmacokinetic properties in healthy participants. The pharmacokinetic profile suggests ...
A Phase 1 study of the safety, tolerability, and ...
A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly ...
Pipeline
Dosing has been completed with the full 96-week readout and post-treatment data being presented at AASLD's The Liver Meeting(R) 2025.
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