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Effect of Long-term (144-week) Entecavir treatment on liver fibrosis in cirrhosis patients infected with hepatitis B virus

Usefulness of transient elastography for assessment of liver fibrosis in liver cirrhosis patients infected with HBV: regression of liver stiffness during long-term Entecavir treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002094
Enrollment
Unknown
Registered
2012-03-03
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic hepatitis B related liver cirrhosis

Interventions

alone group:entecavir oral administration

Sponsors

302 Military Hospital of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Cirrhosis patients with chronic HBV infection based on diagnostic criteria of 2010 China clinical practice guidelines of chronic hepatitis B (updated); 2. Males or females with age from 35 to 65 years old, capable of signing the informed consent; 3. Persistently positive HBsAg for more than 6 months (HBeAg positive, HBV DNA >=1000 IU/ml; HBeAg negative, HBV DNA >=100 IU/ml); 4. Child-Pugh score: A grade; 5. Antiviral treatment native; 6. BIL <=2*ULN; 7. BMI <=28 kg/m2; 8. FibroScan value from 9.3 to 27.0 Kpa.

Exclusion criteria

Exclusion criteria: 1. Combination with liver failure, decompensated cirrhosis, liver tumor, cardio-cerebrovascular disease, The blood system disease, or psychiatric disorders; 2. Enrollment in other clinical trials; 3. Poor compliance or other factors which may lead to mistakes in determine of effect or safety; 4. Allergy, pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
HBV DNA;FibroScan;liver biopsy;

Secondary

MeasureTime frame
ALT normalized rate;HBeAg seroconversion;B ultrasound;hepatic decompensation rate;drug resistance rate;

Countries

China

Contacts

Public ContactChen guo-feng

302 Military Hospital of China

bjchen302@yahoo.com.cn+86 010 66933427

Outcome results

None listed

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