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Entecavir vs tenofovir in the treatment of hepatocellular carcinoma risk in newly treated patients with chronic hepatitis B-related decompensated cirrhosis: a medical records based study

Entecavir vs tenofovir in the treatment of hepatocellular carcinoma risk in newly treated patients with chronic hepatitis B-related decompensated cirrhosis: a single-center hospital liver study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034573
Enrollment
Unknown
Registered
2020-07-10
Start date
2020-07-10
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated hepatitis B cirrhosis patients

Interventions

TDF cohort:Nil
ETV cohort:Nil

Sponsors

Beijing You'an Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Antiviral group: (1) Patients with decompensated hepatitis B cirrhosis were diagnosed according to the diagnostic criteria of liver cirrhosis diagnosis and treatment guidelines issued by hepatology branch of Chinese Medical Association in 2019; (2) In our hospital, regular follow-up can obtain more complete follow-up data of patients; (3) Patients who had not been treated with entecavir, tenofovir or telbivudine before or within half a year showed positive HBsAg and HBV DNA > 102 IU / ml (Cabos E601, Roche diagnosis, Germany). The long-term medication records can be found in the medical record database of our hospital, and the regular medication for 2 years. Before using nucleoside (acid) analogues, the patients had informed consent. (4) Aged 18 to 80 years old. 2. Non antiviral group: (1) Patients with decompensated hepatitis B cirrhosis were diagnosed according to the diagnostic criteria of liver cirrhosis diagnosis and treatment guidelines issued by hepatology branch of Chinese Medical Association in 2019; (2) Patients with complete follow-up data can be obtained by regular follow-up in our hospital; (3) Patients who had not taken antiviral drugs and had a survival time of at least 6 months; (4) Aged 18 to 80 years old.

Exclusion criteria

Exclusion criteria: 1. Patients with other hepatitis virus infection (such as HAV, HCV, HEV, EBV, etc.); 2. Patients who use hepatotoxic drugs for a long time (such as anti-tumor, anti tuberculosis, nervous system drugs, etc.); 3. Patients with primary or metastatic liver cancer; 4. Patients who have stopped taking antiviral therapy for more than 6 months; 5. Patients with uncontrolled cardiovascular, respiratory, digestive, neurological, urinary and other serious diseases; 6. Pregnant or lactating women; 7. Patients with decompensated liver cirrhosis complicated with alcoholic liver disease; 8. Patients with chronic liver failure or acute attack when child Pugh score is greater than 14; 9. Patients considered by other researchers not to meet the study conditions.

Design outcomes

Primary

MeasureTime frame
Incidence of hepatocellular carcinoma;

Secondary

MeasureTime frame
HBV DNA;

Countries

China

Contacts

Public ContactHuiguo Ding

Beijing You'an Hospital Affiliated to Capital Medical University

dinghuiguo@medmail.com.cn+86 13911683832

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026