| Primary | Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline. | Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type). | | Posted | | Count of Participants | | Participants | | Baseline and 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P < 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group). | Chi-squared | | 0.248 | The threshold for statistical significance was p = 0.05 | Mean Difference (Net) | 16.7 | | | 2-Sided | 95 | -11.2 | 44.5 | | | Difference = Canakinumab - Placebo | | |
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| Secondary | Difference in Proportions of Participants With Improvement of Polymorphonuclear Cell Infiltrate From Baseline to Day 28. | Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the proportion of patients, within each treatment group, with improvement on each individual component (polymorphonuclear cell infiltrate, ballooned hepatocytes and steatosis). | | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Baseline and 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Degree of Fibrosis (AHHS) From Baseline to Day 28 | Where presence of bridging fibrosis or Cirrhosis at day 28 is the outcome. Firth logistic regression model was used. An intercept term and treatment indicator are the only predictor variables. | | Posted | | Count of Participants | | Participants | | Baseline and 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28 | Number of patients in whom the histological degree of liver steatosis improved between baseline and day 28. Steatosis is assessed using an ordinal scale (1,2,3,4). There are four categories of steatosis grade: (1) <5%, (2) 5% to 33%, (3) >33% to 66%, and (4) >66% Ordinal logistic regression was used for statistical analysis | | Posted | | Count of Participants | | Participants | No | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Participants Presenting Changes in Hepatic Venous Pressure Gradient (HVPG) Between Baseline and Day 28 | This outcome measure was included in the protocol as a secondary objective. However, no data was generated as HVPG is difficult to obtain and the outcome measure was therefore abandoned | No data collected There was no measurement taken | Posted | | | | | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Participants Presenting Changes in Serum CK18-M30/M65 From Baseline to Day 7, 14, 21, 28, 42 and 90 | Samples were not available. It was reported as a SAP deviation in the final statistical report. | No data collected Data was not available as samples were not available. | Posted | | | | | | Baseline and 7, 14, 21, 28, 42, 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Change in Serum Bilirubin Concentration From Baseline to Day 28 | | Bilirubin levels at day 28 only. | Posted | | Mean | Standard Deviation | micromole/litre | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Change in MELD (Model For End-Stage Liver Disease) Score at From Baseline to Day 28 | MELD score is based on the following formula: MELD Score = (9.57 * ln(Creatinine)) + (3.78 * ln(Bilirubin)) + (11.2 * ln(INR)) + 6.43. Higher score is a worse outcome. Minimum value is around 9 and maximum value is around 40. | Patients with available day 28 MELD score only. | Posted | | Mean | Standard Deviation | MELD difference (Units on a scale) | | Day 0 to day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Change in Glasgow Alcoholic Hepatitis Score (GAHS) From Day 28 | Predicts mortality in patients with alcoholic hepatitis by laboratory results and age. GAHS score is calculated after Forrest et al., 2007 where a score of 5 to 12 is assigned based on age, WCC, Urea, PT ratio or INR and bilirubin. Higher score means a worse outcome and a score greater than or equal to 9 is associated with a poor prognosis. Outcome measure is the score at day 28 - score at day 0 | Patients on whom the Glasgow Alcoholic Hepatitis Score was available at day 28 | Posted | | Number | | score on a scale | | Day 0 to day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Change in Maddrey's Discriminant Function (mDF) Score From Baseline to Day 28 | mDF is calculated using the following formula: mDF = 4.6 x (Prothrombin time - control time) + Serum Bilirubin (μmol/l) / 17. A higher score is associated with poorer prognosis. A value more than 32 implies poor outcome. | | Posted | | Mean | Standard Deviation | score on a scale | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Lille Score at Day 7 | Lille score is calculated as Exp(-R)/[1+exp(-R)] where R = [3.19 - (0.101*age in years)] + (1.47*albumin at baseline in g/dL) + [0.28215* (bilirubin at baseline - bilirubin at Day 8 in mg/dL)] - [0.206 * (if creatinine>=1.3 mg/dL at baseline)] - [0.11115*bilirubin baseline in mg/dL] - (0.0096*Prothrombin Time in seconds at baseline). The Lille Model predicts mortality rates within 6 months. Scores >0.45 predict a 6-month survival of 25%. Scores <0.45 predict a 6-month survival of 85%. | | Posted | | Mean | Standard Deviation | score on a scale | | 7 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Resolution of Systemic Inflammatory Response Syndrome (SIRS) at Day 28 in Patients With SIRS at Baseline | Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
- Temperature < 36 ºC or > 38 ºC
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
- Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
| 6 participants had SIRS at baseline | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Incidence of Systemic Inflammatory Response Syndrome (SIRS) at Day 28 in Patients Without SIRS at Baseline | Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
- Temperature < 36 ºC or > 38 ºC
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
- Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
| 43 participants did not have SIRS at baseline | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Deaths at Day 90 | Number of deaths per arm and hazard ratio. | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Infection Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Acute Kidney Injury Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Variceal Haemorrhage Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Participants With Treatment-related Adverse Events | The safety and tolerability of canakinumab will be assessed through the measurement of a number of participants with treatment-related adverse events. | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Serum and Plasma Biomarkers of Hepatic Function and Inflammation Including Cytokine Profiles Which May Indicate the Degree of Response to IL-1b Inhibition. | Data were not available at time of final analysis. The aim is to monitor baseline levels of cytokines linked to inflammasome activation and their changes after active IMP treatment. The proposed method and cytokines is as follows: MSD 7-plex kit will be used for the detection of the following cytokines: IL-18, IL-1β*, IL-1ra, IL-6, IL-8, IFNγ** and TNF-α ELLA 1-plex will be used for the detection of the following cytokines: IL-18Bpa | Data were not available as serum samples required for the cytokine measurements were lost in a freezer failure. | Posted | | | | | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | CRP Levels at Day 28 | | Number of measurements at day 28 | Posted | | Median | Inter-Quartile Range | milligrams/litre | | 28 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Length of Hospital Stay | | | Posted | | Median | Inter-Quartile Range | days | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Difference in Proportions of Participants With Improvement of Ballooned Hepatocytes Between Treatment Groups. | Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the proportion of patients, within each treatment group, with 95% confidence intervals. | | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Difference in Proportions of Improvement of Steatosis Between Treatment Groups at Day 28 | Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the proportion of patients, within each treatment group, with 95% confidence intervals. | | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Degree of Neutrophil Infiltration (AHHS) From Baseline to Day 28 | Where no/mild polymorphonuclear infiltration at day 28 is the outcome. A logistic regression model was used. An intercept term, baseline measurement and treatment indicator are the only predictor variables. | | Posted | | Count of Participants | | Participants | | day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Presence of Megamitochondria (AHHS) From Baseline to Day 28 | Where no megamitochondria at day 28 is the outcome. Firth logistic regression model was used. An intercept term, baseline measurement and treatment indicator are the only predictor variables. | | Posted | | Count of Participants | | Participants | | day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Type of Bilirubinostasis (AHHS) From Baseline to Day 28 | Where there are 3 outcomes: (1) no or hepatocellular only, (2) ductular or canalicular, (3) canalicular or ductular plus hepatocellular. An ordinal logistic regression model was used. An intercept term, baseline measurement and treatment indicator are the only predictor variables. | | Posted | | Count of Participants | | Participants | | day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Lobular Inflammation (NAS) From Baseline to Day 28 | There are four categories: (1) No foci, (2) < 2 foci per 200x field, (3) 2 to 4 foci per 200x field, and (4) > 4 foci per 200x field. Ordinal logistic regression was used. | | Posted | | Count of Participants | | Participants | | day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients Presenting Changes in Hepatocyte Ballooning (NAS) From Baseline to Day 28 | There are three categories: (1) none, (2) few balloon cells, and (3) many cells/prominent ballooning. Ordinal logistic regression was used. | | Posted | | Count of Participants | | Participants | | day 28 | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Sepsis Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Ascites Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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| Secondary | Number of Patients With Encephalopathy Over 90 Days | | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Canakinumab | A single dose of 3 mg/kg canakinumab administered intravenously at baseline. Canakinumab made up by dilution in 100ml 5% dextrose solution. Patients with AST > 2 x ULN on day 28 receive a second dose of 3mg/kg canakinumab administered the same way. | | OG001 | Placebo | A single injection of 100ml 5% Dextrose solution at baseline. Patients with AST > 2 x ULN on day 28 receive a second injection of the same solution. |
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