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TAK-242 in Patients With Acute Alcoholic Hepatitis
Sponsor: Akaza Bioscience Ltd
Summary
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of alcohol-related cirrhosis due to alcoholic hepatitis resulting in acute-on-chronic liver failure.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Proof-of-Concept, Phase 2a Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-242 in Subjects With Acute Alcoholic Hepatitis Causing Decompensation of Alcohol-related Cirrhosis and Acute-on-Chronic Liver Failure
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2020-11-12
Completion Date
2022-03-31
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
TAK-242
TAK-242 concentrate solution 80 mg/mL for dilution and infusion
Placebo
Matching placebo concentrate solution
Locations (3)
Kings College Hospital
London, United Kingdom
Nottingham University Hospital Queen's Medical Centre
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom