Table 1 Baseline demographics and clinical characteristics of trial participants

From: Autologous macrophage therapy for liver cirrhosis: a phase 2 open-label randomized controlled trial

 

Single infusion

Control

Total

P

N (n = 24)

%

N (n = 24)

%

N (n = 48)

%

Demographic data

Sex

Male

16

67

14

58

30

63

0.7661

Age

Mean (s.d.)

 

57.8 (10.6)

 

60.7 (7.6)

 

59.3 (9.2)

0.2938

Height (cm)

Mean (s.d.)

 

169.7 (9.5)

 

170.6 (9.7)

 

170.1 (9.5)

0.7395

Weight (kg)

Mean (s.d.)

 

86.9 (19.7)

 

93.7 (19.4)

 

90.3 (19.6)

0.2395

BMI

Mean (s.d.)

 

29.9 (5.3)

 

32.2 (6.8)

 

31.1 (6.1)

0.1976

AFP (U l−1)

Median (Q1, Q3)

 

3.5 (2.5, 5.0)

 

3.0 (3.0, 5.0)

 

3.0 (3.0, 5.0)

0.8806

VCTE (kPa)

Mean (s.d.)

 

33.0 (15.7) (n = 19)

 

40.6 (18.3) (n = 18)

 

36.7 (17.2) (n = 37)

0.1822

Laboratory data

Albumin (g l−1)

Mean (s.d.)

 

34.6 (3.8)

 

31.5 (5.2)

 

33.1 (4.7)

0.0246

ALT (U l−1)

Mean (s.d.)

 

32.0 (16.0)

 

37.7 (27.3)

 

34.8 (22.3)

0.3862

Bilirubin (μmol l−1)

Mean (s.d.)

 

33.0 (14.3)

 

36.1 (14.5)

 

34.6 (14.3)

0.4675

INR

Mean (s.d.)

 

1.3 (0.1)

 

1.2 (0.2)

 

1.3 (0.2)

0.0938

Creatinine (μmol l−1)

Mean (s.d.)

 

73.8 (19.4)

 

83.9 (25.1)

 

78.9 (22.8)

0.1282

MELD

Mean (s.d.)

 

11.8 (1.8)

 

12.0 (1.7)

 

11.9 (1.7)

0.8053

Platelets (109 l−1)

Mean (s.d.)

 

96.2 (53.4)

 

115.3 (41.5) (n = 23)

 

105.5 (48.4) (n = 47)

0.1773

Liver disease

Dominant etiology

ALD

13

54

12

50

25

52

1.0000

MASLD

7

29

8

33

15

31

1.0000

PBC

1

4

3

13

4

8

0.6085

Cryptogenic cirrhosis

1

4

1

4

2

4

1.0000

Hemochromatosis

1

4

 

0

1

2

1.0000

Hepatitis C virus

1

4

 

0

1

2

1.0000

Other etiologies for this liver disease

Yes

7

29

1

4

8

17

0.0479

Past medical history

Liver

Ascites

10

42

10

42

20

42

1.0000

Spontaneous bacterial peritonitis

1

4

 

0

1

2

1.0000

Encephalopathy

7

29

8

33

15

31

1.0000

Variceal bleeding

7

29

8

33

15

31

1.0000

Other liver complications

1

4

6

25

7

15

0.0972

Any previous hepatic decompensation

15

63

14

58

29

60

1.0000

Cardiovascular

MI

1

4

1

4

2

4

1.0000

Cerebrovascular accident

 

0

1

4

1

2

1.0000

Other cardiovascular complications

2

8

4

17

6

13

0.6662

Other

Asthma

4

17

2

8

6

13

0.6662

COPD

 

0

2

8

2

4

0.4894

Type 2 diabetes

9

38

10

42

19

40

1.0000

IBD

1

4

4

17

5

10

0.3475

Other rheumatologic conditions

1

4

1

4

2

4

1.0000

Alcohol use

Current use

 

8

33

9

38

17

35

1.0000

Weekly intake

1–10 units

1

4

2

8

3

6

 

11–14 units

1

4

1

4

2

4

 

15–21 units

 

0

1

4

1

2

 

Less frequently

6

25

5

21

11

23

 

Abstinence duration

<6 months

 

0

1

4

1

2

 

1–12 months

4

17

4

17

8

17

 

1–2 years

 

0

2

8

2

4

 

>2 years

11

46

8

33

19

40

 

Missing

1

4

 

0

1

2

 
  1. Data include dominant etiology, comorbidities, recorded alcohol usage and periods of abstinence. Significance was computed using two-sided, two-sample t-tests or non-parametric equivalent, as appropriate. AFP, α-fetoprotein; BMI, body mass index; COPD, chronic obstructive pulmonary disease; IBD, inflammatory bowel disease; MI, myocardial infarction.
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