Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation (HBSAE)
Recruitment status was: Recruiting
In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some are mild but some developed hepatic decompensation or even death.
Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine was found to have better survival than entecavir in chronic HBV with severe AE. Recent study from India found that tenofovir is able to improve survival in chronic HBV with severe AE. The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV with severe AE.
The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for more than 6 months. Severe AE was defined as ALT > 400 U/L, prolongation of prothrombin time > 3 seconds, bilirubin > 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney test. Logistic regression test was applied to analyze the independent association of various variables with outcome. A p value < 0.05 was regarded as significant.
Chronic HBV With Severe Exacerbation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation|
- 6 months survival [ Time Frame: 6 months after treatment begins ] [ Designated as safety issue: No ]6 months survival after treatment begins
- rapid virological response [ Time Frame: 1,2 and 4 weeks after treatment ] [ Designated as safety issue: No ]Evaluate the relationship of rapid virological response ( at 1,2 and 4 weeks) and survival
- HBeAg seroconversion and virological response 1, 2, and 3 years after treatment [ Time Frame: 1,2 and 3 years after treatment ] [ Designated as safety issue: No ]To evaluate the rate of HBeAg seroconversion and virological response 1, 2, and 3 years after treatment in the two arms
- Safety profile [ Time Frame: during and 6 months after treatment ] [ Designated as safety issue: Yes ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Tenofovir
All enrolled patients are randomized to tenofovir arm who receives tenofovir 300 mg qd for 36 months
Other Name: viread
Placebo Comparator: lamivudine
All enrolled patients are randomized to lamivudine arm who received lamivudine 100 mg qd for 6 months, followed by tenofovir for another 30 months.
Other Name: zeffix
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848743
|Kaohsiung Veterans General Hospigal|
|Kaohsiung, Taiwan, 813|
|Kaohsiung Veterans General Hospital|
|Kaohsiung, Taiwan, 813|