Trial · NCT06890039
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the safety of TAK-242 in combination with G-CSF and alone in subjects with sAH and ACLF compared to placebo | Baseline to Day 14 | To assess the safety of TAK-242 in combination with G-CSF (G-TAK) and alone in subjects with sAH and ACLF compared to placebo from baseline to Day 14: * The percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) or SAE. * The percentage of subjects who discontinue the study drug due to an AE (including methemoglobinemia). |
| Secondary | Changes in CLIF-C OF score | Baseline to Day 14 | Changes in CLIF-C OF score in subjects treated with G-TAK compared with placebo from baseline to Day 14 CLIF-C OF (Chronic Liver Failure Organ Failure) - The CLIF-C organ failure (OF) score is used to diagnose acute-on-chronic liver failure (ACLF) in patients with acute decompensation of cirrhosis. Each organ system is scored on a scale to generate the overall CLIF-C OF score, ranging from 0 to 18. A higher CLIF-C OF score translates into a higher ACLF grade. |
| Secondary | Changes in CLIF C ACLF-CRP score | Baseline to Day 84 | Changes in CLIF-C OF score in patients treated with TAK-242 alone compared with G-TAK and placebo, as well as changes in CLIF C ACLF-CRP score between all arms CLIF-C Acute-on-chronic liver failure - c-reactive protein (CLIF-C ACLF-CRP) will be calculated using this formula: CLIF-C ACLF-CRP score = 10 x (0.293 x CLIF-C OF score + 0.034 x Age\[years\] + 0.292 x log(CRP) - 0.8) |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | tmax(hr): Time point where the peak plasma concentration is maximum will be calculated |
| Secondary | To Investigate the effects of TAK-242 alone or in combination with G-CSF, compared with placebo and between active treatment groups, on key biomarkers for inflammation, cell death, liver function, regeneration and senescence | From Baseline to Day 4, 7, and 14 | Changes from baseline after 14 days in naturally log-transformed key liver function biomarkers will include: * total bilirubin (TB) * cleaved Cytokeratin-18 (M30)/ Cytokeratin-18 (M65) * transforming growth factor beta 1 (TGFb1) * interleukin 22 (IL-22) * interleukin 22 binding protein (IL-22BP) * C-reactive protein (CRP) * hepatic growth factor (HGF) * stromal cell-derived factor 1 (SDF-1), * soluble urokinase-type plasminogen activator receptor (suPAR)) * DNA methylation * circulating RNAs (genes MYLK3, SLC22A13, TPRG1-AS1, AC020633.1, TPRG1-AS1, NUDT4P1 Biomarkers of Humoral Inflammation and Cell Death, Cellular inflammation, regeneration \& senescence, metabolic and genetics and mitochondrial function are assessed individually between treatment groups as well as overall, global trends between treatment groups. They are not aggregated to arrive at one reported value. |
| Secondary | To investigate transplant free and overall survival in subjects with sAH and ACLF | Upto Day 84 | To investigate the effect of TAK-242 alone or the combination of TAK-242 and G-CSF (G-TAK) versus placebo on Day 28 and Day 84 transplant free and overall survival in subjects with sAH and ACLF. This is not a scale. Patients either do or do not have a liver transplant during the study period; and either survive or don't survive. |
| Secondary | Change in organ function between different treatment arms. | Baseline to Day 14 | Assessments of organ failure, systemic inflammation, and ACLF |
| Secondary | To investigate the effect on the Quality of Life | Baseline to Day 84 | To investigate the effect of TAK-242 alone or the combination G-TAK compared with placebo and each other on the Quality of Life in subjects with sAH and ACLF. The scoring system that will be used is EQ5D5L, which allows assessment of QoL changes in sick patients Quality of Life scale is scored from 0 to 100, with 0 being worst health you can imagine; 100 best health. |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | t1/2(hr) will be determined from the terminal phase in plasma after drug administration |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | Cmax(ng/mL): highest concentration of a drug in the blood will be calculated |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | Steady-state concentration (Cssng/mL) will be calculated for drug being absorbed in the body when the drug is given continuously or repeatedly |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | AUC last (h\*ng/ml): Area under curve from pre-dose to the last sampling time-point will be calculated |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | AUC infinity (h\*ng/ml): Area under curve from pre-dose to the extrapolated data till the concentration reaches to baseline |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | Total body clearance (L/h) will be calculated |
| Secondary | Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF | Baseline to Day 7 | Total body clearance at steady state (L/h) will be calculated |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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