Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Fifth People's Hospital of Suzhou
• Treatments: Telbivudine

Criteria

Inclusion Criteria:

• liver cirrhosis with CHB

• without history of antiviral therapy or discontinued antiviral therapy for more than 6 months

• for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative

• for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion Criteria:

• coinfection with HCV,HDV and HIV

• AFP≥100mg/L or HCC diagnosed by iconography

• with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases