Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in blood ALT (Alanine-Aminotransferase) in IU/L |
Change in blood ALT in IU/Lin all treatment groups |
at day 35 |
|
Secondary |
Liver enzyme blood parameter AST (Aspartate-Aminotransferase) |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Baseline (prior treatment) |
|
Secondary |
Liver enzyme blood parameter AST |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Day 7 |
|
Secondary |
Liver enzyme blood parameter AST |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Day 14 |
|
Secondary |
Liver enzyme blood parameters: AST |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Day 21 |
|
Secondary |
Liver enzyme blood parameter AST |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter AST |
Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Baseline |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter ALT |
Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Baseline |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase) |
Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups |
Baseline |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/L in all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter AP (Alkaline phosphatase ) |
Change of Liver enzyme blood parameter AP in IU/L in all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Baseline |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter bilirubin |
Change of Liver enzyme blood parameter bilirubin in all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
baseline |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter INR (International Normalized Ratio) |
Change of Liver enzyme blood parameter INR in all treatment groups |
Day 35 |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
baseline |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
Day 7 |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
Day 14 |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
Day 21 |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
Day 28 |
|
Secondary |
Change Liver enzyme blood parameter Quick value |
Change of Liver enzyme blood parameter Quick value in all treatment groups |
Day 35 |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
baseline |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
Day 7 |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
Day 14 |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
Day 21 |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
Day 28 |
|
Secondary |
Change ALT/AP ratio |
Change of ALT/AP ratio in all treatment groups |
Day 35 |
|
Secondary |
Lipids analysis |
LDL (Low Density Lipoproteins) in all treatment groups |
Baseline |
|
Secondary |
Lipids analysis LDL |
LDL (Low Density Lipoproteins) in all treatment groups |
Day 7 |
|
Secondary |
Lipids analysis LDL |
LDL (Low Density Lipoproteins) in all treatment groups |
Day 14 |
|
Secondary |
Lipids analysis LDL |
LDL (Low Density Lipoproteins) in all treatment groups |
Day 21 |
|
Secondary |
Lipids analysis LDL |
LDL (Low Density Lipoproteins) in all treatment groups |
Day 28 |
|
Secondary |
Lipids analysis LDL |
LDL (Low Density Lipoproteins) in all treatment groups |
Day 35 |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
baseline |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
Day 7 |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
Day 14 |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
Day 21 |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
Day 28 |
|
Secondary |
Lipids analysis |
HDL (High Density Lipoproteins) in all treatment groups |
Day 35 |
|
Secondary |
Lipids analysis |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day baseline |
|
Secondary |
Lipids analysis VLDL |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day 7 |
|
Secondary |
Lipids analysis VLDL |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day 14 |
|
Secondary |
Lipids analysis VLDL |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day 21 |
|
Secondary |
Lipids analysis VLDL |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day 28 |
|
Secondary |
Lipids analysis VLDL |
VLDL (very low Density Lipoproteins) in all treatment groups |
Day 35 |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
baseline |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
Day 7 |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
Day 14 |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
Day 21 |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
Day 28 |
|
Secondary |
Lipids analysis triglycerides |
triglycerides in all treatment groups |
Day 35 |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
baseline |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
Day 7 |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
Day 14 |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
Day 21 |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
Day 28 |
|
Secondary |
Lipids analysis total cholesterol |
total cholesterol in all treatment groups |
Day 35 |
|
Secondary |
bloodparameter assessment |
fasting glucose value in all treatment groups |
baseline |
|
Secondary |
bloodparameter assessment |
fasting glucose value in all treatment groups |
Day 7 |
|
Secondary |
blood parameter assessment |
fasting glucose value in all treatment groups |
Day 14 |
|
Secondary |
blood parameter assessment |
fasting glucose value in all treatment groups |
Day 21 |
|
Secondary |
blood parameter assessment |
fasting glucose value in all treatment groups |
Day 28 |
|
Secondary |
blood parameter assessment |
fasting glucose value in all treatment groups |
Day 35 |
|
Secondary |
Proportion of patients with normalization in liver enzyme blood parameters |
normalisation of liver enzyme blood parameters such as AST (< 40 IU/L), ALT (< 40 IU/L), GGT, AP, bilirubin, INR, Quick |
Day 35 |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
Base line |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
day 7 |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
day 14 |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
day 21 |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
day 28 |
|
Secondary |
Plasma silymarin dose concentration |
concentration of silymarin |
day 35 |
|
Secondary |
Fibroscan value |
measurement of Fibroscan |
baseline |
|
Secondary |
Fibroscan value |
measurement of Fibroscan |
day 14 |
|
Secondary |
Fibroscan value |
measurement of Fibroscan |
day 35 |
|
Secondary |
Fibrosis score |
score F0 to F4 |
baseline |
|
Secondary |
Fibrosis score |
score F0 to F4 |
Day 14 |
|
Secondary |
Fibrosis score |
score F0 to F4 |
Day 35 |
|
Secondary |
CAP score |
score measured in dB/m |
baseline |
|
Secondary |
CAP score |
score measured in dB/m |
day 14 |
|
Secondary |
CAP score |
score measured in dB/m |
day 35 |
|
Secondary |
Body Mass Index (BMI) |
index measured in weight and height |
baseline |
|
Secondary |
Silymarin concentration in blood plasma in pharmakokinetic substudy - AUC |
assessement of area under the curve (AUC), |
baseline |
|
Secondary |
Silymarin concentration in blood plasma in pharmakokinetic substudy - tmax |
assessement of time to maximal concentration (tmax) |
baseline |
|
Secondary |
Silymarin concentration in blood plasma in pharmakokinetic substudy - Cmax |
assessement of maximal concentration (Cmax) |
baseline |
|
Secondary |
Treatment adherence |
measured by patient diary |
Baseline |
|
Secondary |
Treatment adherence |
measured by patient diary |
Day 7 |
|
Secondary |
Treatment adherence |
measured by patient diary |
Day 14 |
|
Secondary |
Treatment adherence |
measured by patient diary |
Day 21 |
|
Secondary |
Treatment adherence |
measured by patient diary |
Day 28 |
|
Secondary |
Treatment adherence |
measured by patient diary |
Day 35 |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
baseline |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
Day 7 |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
Day 14 |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
Day 21 |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
Day 28 |
|
Secondary |
quality of life measurements |
measured by short form survey (SF36) questionnaire |
Day 35 |
|