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

Liver Cirrhosis Clinical Trial

Official title:

Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01380951
• Other study ID #: szwy20110610
• Status: Recruiting
• Phase: Phase 4
• First received: June 23, 2011
• Last updated: June 23, 2011
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2011
• Source: The Fifth People's Hospital of Suzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• telbivudine
telbivudine 600mg/d 96 weeks

Locations

Country	Name	City	State
China	the Fifth People's Hospital of Suzhou	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Fifth People's Hospital of Suzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum HBV DNA	serum HBV DNA negativity and decline from baseline at week 48	48 weeks	No
Secondary	Serum HBeAg	rate of HBeAg seroconversion and HBeAg loss	48 weeks	No
Secondary	Child-pugh score	the average decline of Child-pugh score at week 48 from baseline	48 weeks	No