Trial · NCT02854631
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities | Up to Day 28 plus 30 days | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. |
| Secondary | Percentage of Participants Who Died by Day 28 | Day 28 | The percentage of participants who died by Day 28 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 8 | Week 8 | The percentage of participants who died by Week 8 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 12 | Week 12 | The percentage of participants who died by Week 12 was calculated. |
| Secondary | Percentage of Participants Who Died by Week 24 | Week 24 | The percentage of participants who died by Week 24 was calculated. |
| Secondary | Percentage of Participants With Survival at Day 28 Using Kaplan-Meier | Day 28 | The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 8 Using Kaplan-Meier | Week 8 | The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 12 Using Kaplan-Meier | Week 12 | The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants With Survival at Week 24 Using Kaplan-Meier | Week 24 | The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated. |
| Secondary | Percentage of Participants Who Received a Liver Transplant | Day 28, Week 8, Week 12, and Week 24 | The percentage of participants who received a liver transplant by week 24 was calculated. |
| Secondary | Percentage of Participants With Hepatorenal Syndrome (HRS) | Up to 24 weeks | The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria \>500 mg/day, microhematuria (\> 50 red blood cells per high power field) and/or abnormal renal ultrasonography. |
| Secondary | Percentage of Participants With Infection | Up to 24 weeks | The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis). |
| Secondary | Length of Hospital Stay | Up to 24 weeks | Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT) | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST) | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT) | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Bilirubin | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: Albumin | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
| Secondary | Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR) | Baseline (Day 1) and up to 24 weeks | Change from Baseline was calculated as the value at endpoint minus the value at Baseline. |
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.
For software
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