chronic hepatitis C virus infection
Conditions
Interventions
A(chronic hepatitis C):DAAs
B(compensated cirrhosis):DAAs
C(decompensated cirrhosis):DAAs
D(primary hepatocellular carcinoma):DAAs
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic hepatitis C 1. Aged at least 18 years old; 2. Female or male; 3. Diagnosis of chronic hepatitis C:it met any of the following: (1) Anti-HCV and / or HCV RNA was positive for more than 6 months; (2) HCV RNA was positive, liver histopathological examination was consistent with chronic hepatitis; 4. The liver hardness value detected by FibroScan or FibroTouch within 6 months of screening was less than 12.5kPa, or the liver histopathological examination within 1 year before screening indicated no cirrhosis, such as Metavir =F3GS =S3Scheuer =F3Knodell =F3Ishark =F4; 5. Patients received direct antiviral drugs that have been listed in China, including those who would receive direct antiviral drugs, or had received direct antiviral drugs, or were using direct antiviral drugs now; 6. Regular follow-up. Compensated cirrhosis: 1. Aged at least 18 years old; 2. Female or male 3. Diagnosis of chronic HCV infection: anti-HCV and / or HCV was RNA positive for more than 6 months; HCV RNA positive; 4. There were evidences of cirrhosis, which was defined as meeting one of the followings: (1) The liver hardness value detected by FibroScan or FibroTouch within 6 months before screening was more than 12.5 kPa; (2) Liver histopathological examination within 1 year before screening indicated cirrhosis, such as Metavir F4, GS S4, Scheuer F4, Knodell F4, Ishark = F5; (3) Abdominal color ultrasound or CT or magnetic resonance imaging (MRI) in the first 3 months of screening indicated cirrhosis. For example, color ultrasound indicated liver shrinkage, uneven surface, wavy or jagged, dull liver edg, uniform enhanced liver parenchyma echo, and nodular liver tissue. The diameter of portal vein and splenic vein were widen. Hepatic vein was thinning, distorted and uneven thicked; 5. Patients received direct antiviral drugs that have been listed in China, including those who would receive direct antiviral drugs, or had received direct antiviral drugs, or were using direct antiviral drugs now; 6. Regular follow-up. Decompensated cirrhosis: 1. Aged at least 18 years old; 2. Female or male 3. Diagnosis of chronic HCV infection: anti-HCV and / or HCV was RNA positive for more than 6 months; HCV RNA positive; 4. There were evidences of cirrhosis, which was defined as meeting one of the followings: (1) The liver hardness value detected by FibroScan or FibroTouch within 6 months before screening was more than 12.5 kPa; (2) Liver histopathological examination within 1 year before screening indicated cirrhosis, such as Metavir F4, GS S4, Scheuer F4, Knodell F4, Ishark = F5; (3) Abdominal color ultrasound or CT or magnetic resonance imaging (MRI) in the first 3 months of screening indicated cirrhosis. For example, color ultrasound indicated liver shrinkage, uneven surface, wavy or jagged, dull liver edg, uniform enhanced liver parenchyma echo, and nodular liver tissue. The diameter of portal vein and splenic vein were widen. Hepatic vein was thinning, distorted and uneven thicked; 5. Decompensated performance of cirrhosis in the past or screening, such as ascites, esophageal varices bleeding, hepatic encephalopathy and so on.or Child-Pugh score was more than 7 points or Child-Pugh B or C; 6. Patients received direct antiviral drugs that have been listed in China, including those who would receive direct antiviral drugs, or had received direct antiviral drugs, or were using direct antiviral drugs now; 7. Regular follow-up. Primary hepatoce
Exclusion criteria
Exclusion criteria: Chronic hepatitis C (1) previous abdominal color ultrasound or CT or magnetic resonance imaging (MRI) indicated cirrhosis.For examplecolor ultrasound indicated liver shrinkage, uneven surface, wavy or jagged, dull liver edg, uniform enhanced liver parenchyma echo, and nodular liver tissue. The diameter of portal vein and splenic vein were widen. Hepatic vein was thinning, distorted and uneven thicked; (2) Performance of decompensated cirrhosis in the past or screening, such as ascites, esophageal varices bleeding, hepatic encephalopathy, and so on.; (3) Hepatic cancer has been diagnosed before direct antiviral drugs, including histopathological diagnosis, or AFP was more than 100 ng/ml and imaging showed malignant occupation; (4) Patients currently was participating in clinical trials; (5) Patients was unsuitable for the trial. 2. Compensated cirrhosis (1) Performance of decompensated cirrhosis in the past or screening, such as ascites, esophageal varices bleeding, hepatic encephalopathy, and so on; (2) Child-Pugh score was more than 7 points at screening, or Child-Pugh B or C; (3) Hepatic cancer has been diagnosed before direct antiviral drugs, including histopathological diagnosis, or AFP was more than 100 ng/ml and imaging showed malignant occupation; (4) Patients currently was participating in clinical trials; (5) Patients was unsuitable for the trial. 3. Decompensated cirrhosis (1) Hepatic cancer has been diagnosed before direct antiviral drugs, including histopathological diagnosis, or AFP was more than 100 ng/ml and imaging showed malignant occupation; (2) Patients currently was participating in clinical trials; (3) Patients was unsuitable for the trial. 4.Primary hepatocellular carcinoma (1) Patients currently was participating in clinical trials; (2) Patients was unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SVR12; | — |
Countries
China
Contacts
Public ContactXiaohong Zhang
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed