Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

Completed

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

• Registration Number: NCT01958229
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-12
• Primary Completion: 2012-03
• Study Completion: 2013-04
• Status Verified: 2013-10
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-08
• Last Update Submitted: 2013-10-08
• Study First Posted: 2013-10-09
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Male or female 18 to 65 years of age

• Documented chronic hepatitis B defined by ALL of following:

  1. Clinical history compatible with compensated chronic hepatitis B
  2. Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit.

Exclusion Criteria

• Pregnant or nursing
• co-infection with hepatitis C virus (HCV) or HIV
• Clinical or imaging diagnosis of cirrhosis
• Evidence of decreased renal function of creatinine >(=)2x ULN

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCR negativity	week 104
HBeAg seroconversion rate	week 104

Secondary Outcome Measures

Name	Time	Method
Genotypic resistance	week 104
Rate of ALT normalization	week 104

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan