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TAK-242 in Patients With Acute Alcoholic Hepatitis

NCT04620148 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-08-02

No results posted yet for this study

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.

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

DRUG

TAK-242

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

DRUG

Placebo

Matching placebo concentrate solution

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Akaza Bioscience Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2022-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620148 on ClinicalTrials.gov