Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
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.
Chronic Hepatitis B
Roadmap Concept in Chronic Hepatitis B Treatment
24-week PCR Negativity of Telbivudine
PCR Negativity at 52 and 104 Week
HBeAg Seroconversion Rate at 52 and 104 Week
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection|
- PCR negativity [ Time Frame: week 52 ] [ Designated as safety issue: No ]
- HBeAg seroconversion rate [ Time Frame: week 52 ] [ Designated as safety issue: No ]
- PCR negativity [ Time Frame: week 104 ] [ Designated as safety issue: No ]
- HBeAg seroconversion rate [ Time Frame: week 104 ] [ Designated as safety issue: No ]
- Rate of ALT normalization [ Time Frame: week 52 ] [ Designated as safety issue: No ]
- Genotypic resistance [ Time Frame: week 52 ] [ Designated as safety issue: No ]
- Rate of ALT normalization [ Time Frame: week 104 ] [ Designated as safety issue: No ]
- Genotypic resistance [ Time Frame: week 104 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
10 c.c whole blood
|Study Start Date:||December 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|CHB patients without cirrhosis|
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.
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.
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.
- To observe the treatment outcomes.
- To validate the result of super-responder trial.
- To validate the Roadmap Concept.
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.
|National Taiwan University Hospital|
|Taipei City, Taiwan, 100|
|Principal Investigator:||Jia-Horng Kao, Professor||National Taiwan University Hospital|