Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with standard medical therapy

- Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy

Liver Cirrhosis

Acute Kidney Injury

- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3)

Albumin

Standard Medical Treatment

Institute of Liver & Biliary Sciences

To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development

To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development - A Randomised Placebo Controlled Trial- A Pilot Study

Ascitic fluid absolute neutrophil count < 250

Institute of Liver and Biliary Sciences, India

Participants will receive 10 μg/kg, 30 μg/kg or 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion. Three patients with MELD 11-20 will receive 10 μg/kg of F-652. Pharmacokinetic testing will be completed on these subjects. If evaluations demonstrate safety and efficacy signals, the next 3 patients will receive 30 μg/kg. If pharmacokinetic testing demonstrates safety and efficacy signals, the next 3 patients will receive 45 μg/kg. After demonstrating absence of side effects in this group, patients in MELD 21-28 will follow the same dose escalation regiment as the MELD 11-20 group.

Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.

Period 1: F-652 10 μg/kg

Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion

Period 2: F-652 30 μg/kg

Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.

Period 3: F-652 45 μg/kg

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Amount of alcohol consumed on a daily basis measured in grams. A MELD score (model for end state liver disease) ranks the degree of sickness the degree to which a liver transplant is needed. The higher the number the more severe the sickness and the more urgent need for a liver transplant.

Alcohol Consumption by MELD grouping

Number of subjects hospitalized at screening visit. A MELD score (model for end state liver disease) ranks the degree of sickness the degree to which a liver transplant is needed. The higher the number the more severe the sickness and the more urgent need for a liver transplant.

Hospitalized at screening by MELD grouping

The count of subjects who experience serious adverse events

Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.

The Number of Subjects With Unexpected Serious Adverse Events.

Overall Study

Vijay Shah, M.D.

Alcoholic Hepatitis

Participants will receive 10 μg/kg, 30 μg/kg or 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion. Three patients will receive 10 μg/kg of F-652. Pharmacokinetic testing will be completed on these subjects. If evaluations demonstrate safety and efficacy signals, the next 3 patients will receive 30 μg/kg. If pharmacokinetic testing demonstrates safety and efficacy signals, the next 3 patients will receive 45 μg/kg.

F-652

Mayo Clinic in Rochester

Use of F-652 in Patients With Alcoholic Hepatitis

An Open-Label, Cohort Dose Escalation Study to Assess the Safety and Efficacy of F-652 in Patients With Alcoholic Hepatitis

Mayo Clinic

Indiana University

Virginia Commonwealth University

Hennepin County Medical Center, Minneapolis

A phase 2 dose escalating study was carried out. F-652 (10, 30 or 45 μg/kg) administered on day 1 and 7 was tested in 3 patients each with moderate (MELD scores: 11-20) and severe AH (MELD scores: 21-28).

chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients; and non-alcoholic fatty liver disease patients.
ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection gastrointestinal bleeding or jaundice(TB>5NL)within 1 month before enrollment)].
Standary therapy

whole blood, serum, urine, stool, liver tissue

chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.
ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)].
Standary therapy for chronic liver disease with ATI and/or AD.

Acute-on-Chronic Liver Disease Inpatients

Etiology（Related to HBV）

blood routine test

other biochemical parameters of liver function from patients' blood sample

Other Liver Biochemical Parameters

basic biochemical parameters of blood sample

Biochemical Parameters

Serum sodium

liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant.

chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
ALI(acute liver injury): including [ALT>3NL(normal level),AST>3NL or TB>2NL within 1 week before enrollment] or AD(acute decompensation) : including [(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB>5NL) within 1 month before enrollment)]
Standary therapy for chronic liver disease with ATI and/or AD

Acute-on-Chronic Liver Disease

28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate

90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate

Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively.

180-day Mortality Rate and Liver Transplantation Rate

The appearance and number of organ failure（including liver, coagulation, renal, circulation, brain, respiratory system） will be evaluated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit)during patients' hospitalization.

The Appearance and Number of Organ Failure

MELD score, MELD-Na score, CLIF-SOFA score, SOFA score and APACHE scores will be calculated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit) during patients' hospitalization.
MELD：Model for end-stage liver disease MELD-Na： Model for end-stage liver disease - sodium SOFA：sequential organ failure assessment CLIF-SOFA：chronic liver failure-sequential organ failure assessment APACHE：Acute Physiology And Chronic Health Evaluation

Models for Disease Severity

be collected and reported at 28 or last visit before discharge

Serum Bilirubin

Recruitment

28-Days Hospitalization and Observation

Clinic or Telephone Follow-up

Professor Hai Li , Director of Clinical Trials

Liver Failure, Acute on Chronic

Standary therapy for chronic liver disease with ALI and/or AD

Standary therapy

Ditan Hospital of integrated traditional Chinese and Western Medicine Center

Southwest Hospital of Third Military Medical University

Fuzhou general hospital of Xiamen university

Southern hospital infection department

Affiliated Hospital of the Armed Police Logistics College

Henan Provincial People's Hospital

Taihe Hospital

Wuhan Union Hospital of Huazhong University of Science and Technology

Xiangya hospital of Central South University

The First Affiliated Hospital of Jilin University

The Second Hospital of Shandong University

Renji hospital of Shanghai Jiao Tong University School of Medical

Shanghai Public Health Clinical Center

The First Teaching Hospital of Xinjiang Medical University

Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study

Chinese Chronic Liver Failure Consortium Acute-on-Chronic Liver Disease and Failure Study ——a Prospective Multi-center Study in China, the Largest Hepatitis B Virus High-endemic Region.

Hai Li

Professor, Department of Gastroenterology, RenJi Hospital ; Vice Director of the National Digestive Key Laboratory; Youth Commission of Chinese Society of Hepatology.

hepatic encephalopathy/koorts

To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development

Use of F-652 in Patients With Alcoholic Hepatitis

Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study

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