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

Phase 4

• Conditions: Liver Cirrhosis; Chronic Hepatitis B
• Interventions: Drug: telbivudine

• Registration Number: NCT01380951
• Lead Sponsor: The Fifth People's Hospital of Suzhou

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Last Update Submitted: 2011-06-23
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
telbivudine	telbivudine	-

Primary Outcome Measures

Name	Time	Method
Serum HBV DNA	48 weeks	serum HBV DNA negativity and decline from baseline at week 48

Secondary Outcome Measures

Name	Time	Method
Serum HBeAg	48 weeks	rate of HBeAg seroconversion and HBeAg loss
Child-pugh score	48 weeks	the average decline of Child-pugh score at week 48 from baseline

Trial Locations

Locations (1)

the Fifth People's Hospital of Suzhou; 🇨🇳 Suzhou, Jiangsu, China