Programs and studies

Clinical study

PhoenixAH

Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis

StatusNot yet recruiting
TypeTrial
CountriesUnited States
Conditions studiedAlcohol-Associated Hepatitis
Study years2025 (estimated)–2026 (estimated)
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

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

Study description

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.

Study registrations

ClinicalTrials.govNCT06750588
Recorded study locations (1)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

Southern California Research Center, inc

Coronado, California, United States

Recorded site status: Not separately listed. Study location source ↗

Notes from the source review
  • Planned completion date has passed while registry status remains nonterminal; recheck with site.
Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct06750588