Trial | NCT01380951  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. 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.
Study Started
May 31
2011
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Jun 27
2011
Estimate

Drug telbivudine

telbivudine 600mg/d 96 weeks

  • Other names: Sebivo

telbivudine Experimental

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
No Results Posted