From: A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)
All participants (n = 15) | Serelaxin (n = 11) | Placebo (n = 4) | |
---|---|---|---|
Age (years) | 56 (43–69) | 56 (43–69) | 59 (54–63) |
Gender (% male) | 11 (73%) | 8 (73%) | 3 (75%) |
Ethnicity (% Caucasian) | 15 (100%) | 11 (100%) | 4 (100%) |
Aetiology of cirrhosis | |||
Alcohol alone | 10 (67%) | 8 (73%) | 2 (50%) |
NAFLD | 2 (13%) | 1 (9%) | 1 (25%) |
HCV alone | 1 (7%) | 1 (9%) | 0 |
HCV + HBV | 1 (7%) | 0 | 1 (25%) |
Cryptogenic | 1 (7%) | 1 (9%) | 0 |
Child–Pugh class A | 9 (60%) | 6 (54%) | 3 (75%) |
Child–Pugh class B | 6 (40%) | 5 (45%) | 1 (25%) |
Child–Pugh class C | 0 | 0 | 0 |
Current/previous liver-related complications | |||
Ascites | 8 (53%) | 6 (55%) | 2 (50%) |
Spontaneous bacterial peritonitis | 0 | 0 | 0 |
Hepatic encephalopathy | 4 (27%) | 3 (27%) | 1 (25%) |
Variceal bleeding | 5 (33%) | 5 (45%) | 0 |
BMI (kg/m2) | 27.6 (19.8–36.6) | 28.0 (24.1–36.6) | 26.5 (19.8–31.8) |
Systolic BP (mmHg) | 145 (112–173) | 155 (126–173) | 134 (112–149) |
Heart rate (bpm) | 71 (46–97) | 73 (46–97) | 69 (66–71) |
MELD score | 10 (6–14) | 11 (8–14) | 7.5 (6–11) |
Total bilirubin (μmol/L) | 24 (6–44) | 28 (7–44) | 12 (6–17) |
INR | 1.2 (1.0–1.6) | 1.3 (1.1–1.6) | 1.2 (1–1.5) |
Albumin (g/dL) | 34 (23–40) | 34 (23–39) | 36 (30–40) |
Platelet count (× 109/L) | 71 (26–331) | 71 (26–182) | 104 (55–331) |
AST (U/L) | 43 (22–122) | 46 (25–122) | 28 (22–32) |
ALT (U/L) | 37 (10–123) | 37 (12–123) | 26 (10–39) |
Ongoing alcohol use | |||
Yes | 4 (27%) | 3 (27%) | 1 (25%) |