Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

October 8, 2013 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic hepatitis B patients without cirrhosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CHB patients without cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCR negativity
Time Frame: week 52
week 52
HBeAg seroconversion rate
Time Frame: week 52
week 52
PCR negativity
Time Frame: week 104
week 104
HBeAg seroconversion rate
Time Frame: week 104
week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of ALT normalization
Time Frame: week 52
week 52
Genotypic resistance
Time Frame: week 52
week 52
Rate of ALT normalization
Time Frame: week 104
week 104
Genotypic resistance
Time Frame: week 104
week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jia-Horng Kao, Professor, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 1, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200910027M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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