Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis (NCT06750588) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
United States12 participantsStarted 2025-11-05
Plain-language summary
The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH).
The drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role.
The main questions it aims to answer are:
Are multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center.
Participants will:
Be administered multiple ascending dose frequencies of NTR-101 every day for 7 days.
Stay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days.
Keep a diary of their symptoms until the checkups and tests are completed.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers
* Able to provide written informed consent (either from patient or patient's legally authorized representative)
* Male and female patients aged ≥18 years and ≤ 70 years of age
* BMI ≥ 20 to ≤ 40 kg/m2
* Enterococcus faecalis testing
* Susceptibility to NTR-101
* Women of child-bearing potential and male patients must agree to use a medically acceptable method of contraception/ birth control throughout the study duration.
Key Exclusion Criteria:
* Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol
* Participants taking systemic corticosteroids for a specified duration
* Platelet count below specified ranges
* INR and Serum creatinine levels above specified ranges
* Active bacterial or viral infections
* Other or concomitant cause(s) of liver disease as a result of other conditions
* Co-infection with HIV
* Positive urine drug screen
* Any significant systemic or major illness other than liver disease that, in the opinion of the investigator, would preclude the patient from participating in and completing the study or might complicated or exacerbated by the proposed treatments or might confound assessment of investigational product
* If female, known pregnancy, or has a positive serum pregnancy test, or lactating/ breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of adverse events
Timeframe: AEs will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35
2
Changes in liver function will be evaluated
Timeframe: Assessments will be recorded daily for 7 days, then weekly on days 14, 21, 28 and 35