Study of Telbivudine in Chronic Hepatitis B
Recruitment status was Recruiting
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.
Chronic Hepatitis B
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.|
Serum will be stored at screening/baseline and complete study after corresponding with inclusion/exclusion criteria.
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
|Contact: Hsiang-min Kung||+886-3-3281200 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|LinKou, Taoyuan County, Taiwan|
|Contact: Hsiang-min Kung +886-3-3281200 ext 2224 email@example.com|
|Principal Investigator: Chau-ting Yeh, MD, PhD|
|Sub-Investigator: Chao-Wei Hsu, MD|
|Principal Investigator:||Chau-ting Yeh, MD,PhD||Chang Gung Memorial Hospital|