Study of Telbivudine in 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.|
- HBV-DNA < 300 Copies/mL in 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2009|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970216
|Chang Gung Memorial Hospital|
|LinKou, Taoyuan County, Taiwan|
|Principal Investigator:||Chau-ting Yeh, MD,PhD||Chang Gung Memorial Hospital|