A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis (INT787-201)
Sponsor: |
Intercept Pharmaceuticals, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAV2701 |
U.S. Govt. ID: |
NCT05639543 |
Contact: |
Thresiamma Lukose: 212-305-7482 / tcrcstudyreferral@cumc.columbia.edu |
The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated hepatitis. This is a double-blind study, so the study doctors and participants will not know if they are receiving INT-787 or a placebo. Participation will last approximately 3 months. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC)
Investigator
Elizabeth Verna, MD
Are between the ages of 18 and 65 years old? |
Yes |
No |
Have you been diagnoses with alcoholic hepatitis? |
Yes |
No |