Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
NCT04160897 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000
Last updated 2019-11-13
Summary
The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF. This study is based on a real-world clinical cohort to retrospectively analyze the effects of ETV and TDF on the long-term (5-year) incidence of HCC in Chinese patients with chronic hepatitis B with compensated cirrhosis. The results will guide the revision of the Chinese HBV guidelines.
Conditions
- Hepatitis B, Chronic
- Hepatocellular Carcinoma
- Compensated Cirrhosis
Interventions
- DRUG
-
Entecavir
entecavir naive for chronic hepatitis B patients
- DRUG
-
Tenofovir Disoproxil
tenofovir disopropyl naive for chronic hepatitis B patients
Sponsors & Collaborators
-
Shanghai MedSci Healthcare Co. Ltd
collaborator UNKNOWN -
Qing XIe
lead OTHER
Principal Investigators
-
Qing Xie, MD · Director of Department of Infectious Disease, Rui Jin Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-22
- Primary Completion
- 2020-10-31
- Completion
- 2020-10-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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