Trial Outcomes & Findings for Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study (NCT NCT02457637)
NCT ID: NCT02457637
Last Updated: 2020-08-11
Results Overview
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.
COMPLETED
2600 participants
up to 28 days
2020-08-11
Participant Flow
Only INPATIENTS who met inclusion criteria were recruited.
Did not meet inclusion criteria (n = 1,306) ;Age \<15 years or ≥80 years (n = 36);Pregnant (n = 22);Liver malignancies (n = 514);Malignancies in other organs (n = 77);Severe chronic extrahepatic disease (n = 107);Received immunosuppressive drugs for reasons other than chronic liver disease (n = 21);Withdrew informed consent (n = 73);Other (n = 205)
Participant milestones
| Measure |
Acute-on-Chronic Liver Disease Inpatients
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
Recruitment
STARTED
|
2600
|
|
Recruitment
COMPLETED
|
2600
|
|
Recruitment
NOT COMPLETED
|
0
|
|
28-Days Hospitalization and Observation
STARTED
|
2600
|
|
28-Days Hospitalization and Observation
Liver Transplantation
|
124
|
|
28-Days Hospitalization and Observation
Death
|
74
|
|
28-Days Hospitalization and Observation
COMPLETED
|
2600
|
|
28-Days Hospitalization and Observation
NOT COMPLETED
|
0
|
|
Clinic or Telephone Follow-up
STARTED
|
2600
|
|
Clinic or Telephone Follow-up
One-year Liver Transplantation
|
182
|
|
Clinic or Telephone Follow-up
One-year Death
|
475
|
|
Clinic or Telephone Follow-up
COMPLETED
|
2529
|
|
Clinic or Telephone Follow-up
NOT COMPLETED
|
71
|
Reasons for withdrawal
| Measure |
Acute-on-Chronic Liver Disease Inpatients
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
Clinic or Telephone Follow-up
Lost to Follow-up
|
71
|
Baseline Characteristics
Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study
Baseline characteristics by cohort
| Measure |
Acute-on-Chronic Liver Disease Inpatients
n=2600 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\].
3. Standary therapy for chronic liver disease with ATI and/or AD.
|
|---|---|
|
Age, Continuous
|
48.34 years
STANDARD_DEVIATION 12.28 • n=93 Participants
|
|
Sex: Female, Male
Female
|
685 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1915 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2600 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
China
|
2600 Participants
n=93 Participants
|
|
Etiology（Related to HBV）
Related to HBV
|
1859 Participants
n=93 Participants
|
|
Etiology（Related to HBV）
Not related to HBV
|
741 Participants
n=93 Participants
|
|
blood routine test
White blood cell
|
5.90 cell *10^9/L
STANDARD_DEVIATION 4.64 • n=93 Participants
|
|
blood routine test
Platelet
|
109 cell *10^9/L
STANDARD_DEVIATION 78 • n=93 Participants
|
|
INR
|
1.64 ratio
STANDARD_DEVIATION 0.78 • n=93 Participants
|
|
Other Liver Biochemical Parameters
Alanine aminotransferase
|
328.21 U/L
STANDARD_DEVIATION 515.93 • n=93 Participants
|
|
Other Liver Biochemical Parameters
Aspartate aminotransferase
|
262.07 U/L
STANDARD_DEVIATION 98.69 • n=93 Participants
|
|
Other Liver Biochemical Parameters
γ-Glutamyltransferase
|
127.78 U/L
STANDARD_DEVIATION 182.83 • n=93 Participants
|
|
Other Liver Biochemical Parameters
Alkaline phosphatase
|
153.13 U/L
STANDARD_DEVIATION 126.70 • n=93 Participants
|
|
Biochemical Parameters
Serum bilirubin
|
9.30 mg/dL
STANDARD_DEVIATION 10.32 • n=93 Participants
|
|
Biochemical Parameters
Serum creatinine
|
0.87 mg/dL
STANDARD_DEVIATION 0.63 • n=93 Participants
|
|
Serum sodium
|
137.38 mmol/L
STANDARD_DEVIATION 5.94 • n=93 Participants
|
PRIMARY outcome
Timeframe: up to 28 daysPopulation: liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by liver-transplantation free participants
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.
Outcome measures
| Measure |
Acute-on-Chronic Liver Disease
n=2600 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate
28-day Mortality
|
74 Participants
|
|
28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate
28-day Liver Transplantation Rate at 28 days
|
124 Participants
|
|
28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate
28-day liver transplantation free mortality
|
74 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Acute-on-Chronic Liver Disease
n=2600 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate
90-day mortality rate
|
333 Participants
|
|
90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate
90-day liver transplantation rate
|
171 Participants
|
|
90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate
90-day liver transplantation free mortality
|
333 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysPopulation: 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.
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.
Outcome measures
| Measure |
Acute-on-Chronic Liver Disease
n=2600 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
180-day Mortality Rate and Liver Transplantation Rate
180-day mortality rate
|
403 Participants
|
|
180-day Mortality Rate and Liver Transplantation Rate
180-day liver transplantation rate
|
177 Participants
|
|
180-day Mortality Rate and Liver Transplantation Rate
180-day liver transplantation free mortality'
|
403 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 28 daysThe 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.
Outcome measures
| Measure |
Acute-on-Chronic Liver Disease
n=2600 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
The Appearance and Number of Organ Failure
|
261 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 28 daysMELD 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 28 daysPopulation: participants who had TB analysis at 28 day after administration
be collected and reported at 28 or last visit before discharge
Outcome measures
| Measure |
Acute-on-Chronic Liver Disease
n=1011 Participants
1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients,.
2. ALI(acute liver injury): including \[ALT\>3NL(normal level),AST\>3NL or TB\>2NL within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding or jaundice(TB\>5NL) within 1 month before enrollment)\]
3. Standary therapy for chronic liver disease with ATI and/or AD
|
|---|---|
|
Serum Bilirubin
|
9.3 mg/dL
Standard Deviation 10.32
|
Adverse Events
Acute-on-Chronic Liver Disease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Hai Li , Director of Clinical Trials
Renji Hospital, Shanghai Jiao Tong University School of Medical
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place