At a glance
ClinicalIndex Comparison RecordN/ACompleted· 160 enrolled
Drug / intervention
Telbivudinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.
In Brief
An observational study evaluating Telbivudine for Chronic Hepatitis B. Completed, enrolled 160 participants across 1 site.
Detailed 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, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesTaiwan
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedSep 2009
Primary CompletionJan 2016
TodayJul 2026
First PostedSep 2, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 16.8 years ago
Interventions
Telbivudinedrug
Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment