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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01380951

Enrollment

120

Registered

2011-06-27

Start date

2011-05-31

Completion date

2013-12-31

Last updated

2011-06-27

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

Conditions

Chronic Hepatitis B, Liver Cirrhosis

Keywords

liver cirrhosis, chronic hepatitis B, antiviral therapy, telbivudine

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.

Interventions

DRUGtelbivudine

telbivudine 600mg/d 96 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serum HBV DNA	48 weeks	serum HBV DNA negativity and decline from baseline at week 48

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026