Study of Telbivudine in Chronic Hepatitis B

January 31, 2016 updated by: Chang Gung Memorial Hospital

A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or 60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary objective: To evaluate the antiviral efficacy of telbivudine by maintained suppression of HBV DNA(<=300 copies/ml or 60 IU/ml,undetectable by current PCR-based assays) in HBeAg positive patients from Week 24 to Week 48.

Methodology: This will be an open-label, prospective, observational, single-center and single arm post marketing surveillance study.

Number of patients: It is estimated to enroll 240 intent-to-treat patients in Taiwan.

Population: Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.

Study Type

Observational

Enrollment (Actual)

160

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
      • LinKou, Taoyuan County, Taiwan
        • Chang Gung memorial 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.

Description

Inclusion Criteria:

  1. Male or female, at least 18 years of age.

  2. Documented chronic hepatitis B defined by all of the following:

    • Clinical history compatible with chronic hepatitis B.
    • Detectable serum hepatitis B surface antigen >= 6 months at screening visit, with either HBeAg positive or negative.
  3. Willing and able to comply with the observational drug regimen and all other study requirements.
  4. Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Females who are pregnant,intending to become pregnant or breast feeding.
  2. Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
  3. Patients with hypersensitivity to telbivudine or to any of the excipients.
  4. One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
  5. Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
  6. Unable to receive safety and tolerability assessments.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBV-DNA < 300 Copies/mL in 48 Weeks
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chau-ting Yeh, MD,PhD, Chang Gung memorial hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMST-Y-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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