Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

Chronic Hepatitis B Clinical Trial

Official title: A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection

Status Completed

Clinical Trial Summary

This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.

Clinical Trial Description

This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.

Study purpose:

This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.

Objectives:

Primary:

To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.

Secondary:

1. To observe the treatment outcomes.

2. To validate the result of super-responder trial.

3. To validate the Roadmap Concept.

Population:

The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 24-week PCR Negativity of Telbivudine
• Chronic Hepatitis B
• HBeAg Seroconversion Rate at 52 and 104 Week
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• PCR Negativity at 52 and 104 Week
• Roadmap Concept in Chronic Hepatitis B Treatment

• NCT number: NCT01958229
• Study type: Observational
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Completion date: April 2013