Table 1: Eligibility criteria of patients in the study.
Inclusion Criteria 1.
Alcoholic cirrhotics between 18-65 years of age (both inclusive)
(diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or
histological evidence of cirrhosis and portal hypertension). 2.
Evidence of decompensated liver disease at screening (Child class B or
C, Child-Pugh scores of ≥7 and <14). 3.
MELD scores of at least 10. 4.
Normal AFP Level (Normal AFP level to be considered as ≤ 40 ng/ml) 5.
Hb>10gm/dl. 6.
Female of childbearing potential should use double contraception, of
which one should be a barrier method during the course of the study 7.
Signed informed consent. |
Exclusion Criteria 1.
Patients listed for liver transplantation during screening 2.
Presence of advanced hepatic encephalopathy Grades 3 & 4 (West
Haven criteria for grading of hepatic encephalopathy) at the time of
screening. 3.
Active variceal bleed. 4.
Refractory ascites. 5.
Evidences of autoimmune liver disease: ANA (beyond 1:120 by
immunoflourescence) or Anti-LKM positivity. 6.
Platelet count < 50,000/mm3. 7.
Serum Sodium <129mEq/L. 8.
Serum Creatinine > 1.2 mg/dl. 9.
Hepatocellular carcinoma or other malignancies 10.
Active infection in the body. 11.
Presence of severe underlying cardiac, pulmonary or renal disease. 12.
Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months
before screening. 13.
Positive HbSAg or antibodies to HIV or HCV. 14.
Pregnancy or lactation. 15.
Participation in any clinical trial within last 1 year 16.
Patients unable to consent 17.
Patients with hypersensitivity to the IMP and non-ionic radio contrast
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