Trials / Unknown
UnknownNCT04620148
TAK-242 in Patients With Acute Alcoholic Hepatitis
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Akaza Bioscience Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-242 | TAK-242 concentrate solution 80 mg/mL for dilution and infusion |
| DRUG | Placebo | Matching placebo concentrate solution |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2020-11-06
- Last updated
- 2021-08-02
Source: ClinicalTrials.gov record NCT04620148. Inclusion in this directory is not an endorsement.