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TERMINATED
NCT04620148
PHASE2

TAK-242 in Patients With Acute Alcoholic Hepatitis

Sponsor: Akaza Bioscience Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

TAK-242

TAK-242 concentrate solution 80 mg/mL for dilution and infusion

DRUG

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