Status:
COMPLETED
Study of Telbivudine in Chronic Hepatitis B
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
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, undetecta...
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 patie...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age.
- 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.
- Willing and able to comply with the observational drug regimen and all other study requirements.
- Willing and able to provide written informed consent to participate in the study.
Exclusion
- Females who are pregnant,intending to become pregnant or breast feeding.
- Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
- Patients with hypersensitivity to telbivudine or to any of the excipients.
- 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.
- Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
- Unable to receive safety and tolerability assessments.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00970216
Start Date
February 1 2009
End Date
January 1 2016
Last Update
February 29 2016
Active Locations (1)
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1
Chang Gung Memorial Hospital
LinKou, Taoyuan County, Taiwan