A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
|ClinicalTrials.gov Identifier: NCT01264094|
Recruitment Status : Terminated (Enrollment)
First Posted : December 21, 2010
Last Update Posted : July 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Clevudine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period|
|Study Start Date :||November 2009|
|Primary Completion Date :||November 2014|
|Study Completion Date :||June 2015|
- Proportion of patients with HBV DNA below the assay limit of detection
- The change of HBV DNA from the baseline.
- Proportion of patients with HBeAg loss and/or seroconversion.
- Biochemical improvement (e.g. ALT normalization).
- Proportion of sAg loss
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264094
|Korea, Republic of|
|Gangnam Severance Hospital|
|Seoul, Korea, Republic of|