A Phase 2 interventional study of TAK-242 and Placebo in Acute-On-Chronic Liver Failure, sponsored by Akaza Bioscience Ltd. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-02.
Sponsored by Akaza Bioscience Ltd · Phase 2, Interventional, and Treatment
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's planned enrollment of 100 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →This is the only study on the registry with Akaza Bioscience Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be administered TAK-242 as a continuous IV infusion with standard care starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 7 days
Drug: TAK-242
Patients will be administered placebo as a continuous IV infusion with standard care starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 7 days
Drug: Placebo
TAK-242 concentrate solution 80 mg/mL for dilution and infusion
Matching placebo concentrate solution
Change in CLIF-C ACLF score from baseline to Day 8
Time frame: Baseline to Day 8
Percentage of subjects who experience at least 1 markedly abnormal treatment-emergent AE or SAE
The percentage of subjects who experience at least 1 treatment-emergent AE or SAE that meets the Sponsor's markedly abnormal criteria
Time frame: To Day 28
Percentage of subjects who experience at least 1 treatment-emergent clinical laboratory test result or abnormal ECG that meets the Sponsor's markedly abnormal criteria
The percentage of subjects who experience at least 1 treatment-emergent clinical laboratory test result or abnormal ECG that meets the Sponsor's markedly abnormal criteria
Time frame: To Day 28
Percentage of subjects who discontinue study drug due to an AE
Time frame: To Day 28
Change in naturally log-transformed key biomarkers
Change in naturally log-transformed key biomarkers (TB, IL-8, high sensitivity CRP \[hs-CRP\], and urinary NGAL)
Time frame: Baseline to day 8
Survival at Day 28 after initiation of TAK-242 therapy versus placebo
Time frame: Baseline to Day 28
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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