Table 3 Clinical outcome indicators at Day 28
Phase Ia | Phase Ib | Total n (%) | |||||
|---|---|---|---|---|---|---|---|
Cohort I (n = 3) | Cohort II (n = 3) | Cohort III (n = 6) | Cohort IV (n = 3) | Cohort A (n = 3) | Cohort B (n = 6) | ||
MELD score changes | |||||||
Up | 2 | 2 | 3 | 0 | 2 | 0 | 9 |
Down | 1 | 0 | 1 | 3 | 1 | 3 | 9 |
Unchanged | 0 | 1 | 2 | 0 | 0 | 3 | 6 |
Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Child–Pugh score changes | 0 | ||||||
Up | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
Down | 1 | 2 | 3 | 2 | 3 | 5 | 16 |
Unchanged | 1 | 0 | 2 | 1 | 0 | 1 | 5 |
Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
EQ-5D-5L scale utility index changes | 0 | ||||||
Up | 1 | 0 | 2 | 0 | 1 | 4 | 8 |
Down | 0 | 1 | 1 | 2 | 0 | 1 | 5 |
Unchanged | 3 | 1 | 2 | 1 | 2 | 1 | 10 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
EQ-5D-5L scale VAS Score | 0 | ||||||
Up | 1 | 0 | 2 | 1 | 0 | 3 | 7 |
Down | 1 | 1 | 3 | 2 | 2 | 2 | 11 |
Unchanged | 1 | 1 | 0 | 0 | 1 | 1 | 4 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Chronic Liver Disease Questionnaire Score | 0 | ||||||
Up | 2 | 0 | 1 | 2 | 2 | 6 | 13 |
Down | 1 | 2 | 4 | 1 | 1 | 0 | 9 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Incidence of complications in DLC, n | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
Survival without liver transplantation, n | 3 | 3 | 6 | 3 | 3 | 6 | 24 |
Occurrence of liver failure, n | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Incidence of liver cancer, n | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Albumin (g/L) | 0 | ||||||
Up | 1 | 2 | 4 | 1 | 3 | 5 | 16 |
Down | 2 | 1 | 2 | 2 | 0 | 0 | 7 |
Unchanged | 0 | 0 | 1 | 0 | 0 | 1 | 2 |
Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Prealbumin (g/L) | 0 | ||||||
Up | 2 | 1 | 3 | 2 | 1 | 5 | 14 |
Down | 1 | 1 | 2 | 1 | 2 | 1 | 8 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Total bilirubin (μmol/L) | 0 | ||||||
Up | 2 | 2 | 4 | 0 | 2 | 3 | 13 |
Down | 1 | 1 | 2 | 3 | 1 | 3 | 11 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Lactic dehydrogenase (U/L) | 0 | ||||||
Up | 1 | 2 | 2 | 1 | 3 | 5 | 14 |
Down | 1 | 0 | 3 | 2 | 0 | 1 | 7 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
Cholinesterase (U/L) | 0 | ||||||
Up | 2 | 1 | 5 | 3 | 3 | 4 | 18 |
Down | 1 | 1 | 0 | 0 | 0 | 2 | 4 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Total bile acid (μmol/L) | 0 | ||||||
Up | 3 | 1 | 2 | 2 | 2 | 3 | 13 |
Down | 0 | 1 | 3 | 1 | 1 | 3 | 9 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Prothrombin activity (%) | 0 | ||||||
Up | 1 | 2 | 2 | 3 | 1 | 5 | 14 |
Down | 2 | 1 | 4 | 0 | 2 | 1 | 10 |
Unchanged | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
