Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis (NCT06750588)
Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Southern California Research Center, inc — Coronado, California
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Southern California Research Center, inc — Coronado, California
📞 Contact the Study Coordinator
Phone: +61 (0) 411821040
Email: info@phageconsulting.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Alcohol-Associated Hepatitis
- Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial — Indianapolis, Indiana
Explore by condition: All Alcohol-Associated Hepatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.