Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
|ClinicalTrials.gov Identifier: NCT01958229|
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : October 9, 2013
|Condition or disease|
|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|
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.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection|
|Study Start Date :||December 2009|
|Primary Completion Date :||March 2012|
|Study Completion Date :||April 2013|
|CHB patients without cirrhosis|
- PCR negativity [ Time Frame: week 52 ]
- HBeAg seroconversion rate [ Time Frame: week 52 ]
- PCR negativity [ Time Frame: week 104 ]
- HBeAg seroconversion rate [ Time Frame: week 104 ]
- Rate of ALT normalization [ Time Frame: week 52 ]
- Genotypic resistance [ Time Frame: week 52 ]
- Rate of ALT normalization [ Time Frame: week 104 ]
- Genotypic resistance [ Time Frame: week 104 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958229
|National Taiwan University Hospital|
|Taipei City, Taiwan, 100|
|Principal Investigator:||Jia-Horng Kao, Professor||National Taiwan University Hospital|