Kidney function may change how hepatitis b drug works
NCT ID NCT07342881
First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This early study tests a single dose of the drug pevifoscorvir in 30 people with chronic hepatitis B, some with kidney problems and some with healthy kidneys. Researchers want to see how kidney function affects drug levels and safety. The goal is to learn how to dose the drug properly for patients with kidney impairment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pevifoscorvir sodium (ALG-000184)
- What this could lead to
- If successful, this study could help doctors decide the right dose of pevifoscorvir for people with kidney problems and chronic hepatitis B.
- What could go wrong
- This is a very early Phase 1 study with only 30 people. It looks at how the body processes the drug, not whether it works for hepatitis B. Results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Mar 2026
- Finished
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Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for All Subjects: 1. Male and Female between 18 and 75 years old 2. Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy Inclusion Criteria for Subjects with Normal Renal Function: 1. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment 2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, sex 3. Normal renal function (estimated Glomerular Filtration Rate \[eGFR\] ≥90 mL/min) with no known or suspected renal impairment Inclusion Criteria for Subjects with Impaired Renal Function: 1. Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration 2. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included). 3. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening 4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria Exclusion Criteria for All Subjects: 1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation 2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or recent history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc. 3. Subjects with a history of clinically significant drug allergy 4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use 5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men 6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up 7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection 8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>2x upper limit of normal (ULN) 9. Subjects with bilirubin (total, direct) \>1.5x ULN (unless Gilbert's is suspected) 10. Positive pregnancy test; females must not be pregnant at enrollment Exclusion Criteria for Subjects with Normal Renal Function: 1\. Hemoglobin \<10 g/dL Exclusion Criteria for Subjects with Impaired Renal Function: 1. Participants requiring hemodialysis and/or peritoneal dialysis 2. Hemoglobin \<9 g/dL
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Genesis Clinical Trials
Tampa, Florida, 33603, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.