Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine

A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005238

Acronym

SASL28

Enrollment

Registered

2009-10-30

Start date

2009-09-30

Completion date

Unknown

Last updated

2015-03-10

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

Conditions

Hepatitis, Chronic

Brief summary

The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.

Interventions

DRUGLamivudine

DRUGTelbivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients, \> 18 (having completed their 18th birthday). There is no upper limit of age * Documented HBeAg negative CHB * HBsAg positive \> 6 months * HBV DNA \> 2000 IU/mL * Patient is willing and able to comply with the study drug regimen and all other study requirements. * Written informed consent * Anti-viral HBV treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening

Exclusion criteria

* Decompensated liver cirrhosis according to the judgment of the local investigator * Hepatocellular carcinoma * History of or laboratory signs of co-infection with HIV or HCV, HDV * Previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.	The primary efficacy endpoint is the rate of viral breakthrough at week 108.

Countries

Switzerland

Outcome results

None listed

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