Hepatitis C
Conditions
Interventions
Case series:direct antiviral drugs (DAAs)
Sponsors
Beijing university people's hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic hepatitis C population: 1. at the age of more than 18 years of screening; 2. gender is not limited; 3. diagnosis of chronic hepatitis C: Chronic hepatitis C is defined as: conforming to any of the following: (1) was positive for -HCV and / or HCV RNA for more than 6 months; (2) was positive for -HCV and / or HCV RNA, and the liver histopathological examination accords with chronic hepatitis; 4. screening and detection of FibroScan or FibroTouch within 6 months before the liver stiffness values less than or equal to 12.5kPa, or screening of liver tissue within 1 years before the examinations showed no cirrhosis, such as Metavir = F3, GS = S3, Scheuer = F3, Knodell = F3, Ishark = F4; 5. patients who receive direct antiviral treatment have been prepared to receive direct antiviral treatment, or have received direct antiviral treatment before, or are undergoing direct antiviral treatment. 6. regular follow-up. People with compensatory cirrhosis: 1. at the age of more than 18 years of screening; 2. gender is not limited; 3. diagnosis of chronic hepatitis C: Chronic hepatitis C is defined as: conforming to any of the following: (1) was positive for -HCV and / or HCV RNA for more than 6 months. (2) was positive for -HCV and / or HCV RNA, and the liver histopathological examination accords with chronic hepatitis. 4. the evidence of liver cirrhosis is defined to be in accordance with any of the following: The liver hardness value of FibroScan or FibroTouch detected by (1) within 6 months before screening was > 12.5kPa; (2) screening of liver tissue within 1 years before the examination of liver cirrhosis, such as Metavir F4, GS S4, Scheuer F4, Knodell F4, Ishark = F5; (3) 3 months before the screening of abdominal ultrasound or CT or MRI (MRI) liver cirrhosis, liver ultrasound showed such as narrow, uneven surface, wavy or zigzag, hepatic blunt edge, liver parenchyma echo uneven, nodular enhancement, portal vein and splenic vein endoscopic widened, hepatic vein thin, twisted, uneven thickness; 5. patients who receive direct antiviral treatment have been prepared to receive direct antiviral treatment, or have received direct antiviral treatment before, or are undergoing direct antiviral treatment; 6. regular follow-up. Patients with decompensated cirrhosis: 1. at the age of more than 18 years of screening; 2. gender is not limited; 3. diagnosis of chronic hepatitis C: Chronic hepatitis C is defined as: conforming to any of the following: (1) was positive for -HCV and / or HCV RNA for more than 6 months. (2) was positive for -HCV and / or HCV RNA, and the liver histopathological examination accords with chronic hepatitis; 4. the evidence of liver cirrhosis is defined to be in accordance with any of the following: The liver hardness value of FibroScan or FibroTouch detected by (1) within 6 months before screening was > 12.5kPa; (2) screening of liver tissue within 1 years before the examination of liver cirrhosis, such as Metavir F4, GS S4, Scheuer F4, Knodell F4, Ishark = F5; (3) 3 months before the screening of abdominal ultrasound or CT or MRI (MRI) liver cirrhosis, liver ultrasound showed such as narrow, uneven surface, wavy or zigzag, hepatic blunt edge, liver parenchyma echo uneven, nodular enhancement, portal vein and splenic vein endoscopic widened, hepatic vein thin, twisted, uneven thickness; 5. previous or screening have decompensated cirrhosis, including but not limited to ascites, variceal b
Exclusion criteria
Exclusion criteria: Chronic hepatitis C population: (1) previous abdominal ultrasound or CT or MRI (MRI) liver cirrhosis, liver ultrasound showed such as narrow, uneven surface, wavy or zigzag, hepatic blunt edge, liver parenchyma echo uneven, nodular enhancement, portal vein and splenic vein endoscopic widened, hepatic vein became thinner, twisted, uneven thickness; (2) the performance of decompensated cirrhosis in the past or screening, including but not limited to ascites, esophageal and gastric fundus variceal bleeding, hepatic encephalopathy, etc. (3) liver cancer has been confirmed before using direct disease resistant drugs, including histopathological diagnosis, or AFP greater than 100ng/ml, and imaging suggests the possibility of malignant occupying. (4) the combination of other malignant tumors; (5) patients who are currently taking part in clinical trials; (6) the researchers thought it was not suitable for the patients who participated in this experiment. People with compensatory cirrhosis: (1) the performance of decompensated cirrhosis in the past or screening, including but not limited to ascites, esophageal and gastric fundus variceal bleeding, hepatic encephalopathy, etc. (2) screening Child-Pugh score more than 7 cent, score for B or C; (3) liver cancer has been confirmed before using direct disease resistant drugs, including histopathological diagnosis, or AFP greater than 100ng/ml, and imaging suggests the possibility of malignant occupying. (4) the combination of other malignant tumors; (5) patients who are currently taking part in clinical trials; (6) the researchers thought it was not suitable for the patients who participated in this experiment. Patients with decompensated cirrhosis: (1) liver cancer has been confirmed before using direct disease resistant drugs, including histopathological diagnosis, or AFP greater than 100ng/ml, and imaging suggests the possibility of malignant occupying. (2) the combination of other malignant tumors; (3) patients who are currently taking part in clinical trials; (4) the researchers thought it was not suitable for the patients who participated in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Drug interaction;Child-Pugh score;Cumulative rate of decompensation;The cumulative incidence of HCC;survival rate;Cumulative incidence of liver transplantation; | — |
Countries
China
Contacts
Public ContactLai Wei
Department of Hepatology, Peking University People's Hospital
Outcome results
None listed