Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation (HBSAE)
|ClinicalTrials.gov Identifier: NCT01848743|
Recruitment Status : Unknown
Verified September 2014 by Wei-Lun Tsai, Kaohsiung Veterans General Hospital..
Recruitment status was: Recruiting
First Posted : May 7, 2013
Last Update Posted : September 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic HBV With Severe Exacerbation||Drug: Tenofovir Drug: lamivudine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||October 2016|
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
- 6 months survival [ Time Frame: 6 months after treatment begins ]6 months survival after treatment begins
- rapid virological response [ Time Frame: 1,2 and 4 weeks after treatment ]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 ]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 ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848743
|Contact: Wei-Lun Tsai, M.D.||886-7-3422121 ext firstname.lastname@example.org|
|Contact: Hoi-Hung Chnan, M.D., PhD||886-7-3422121 ext email@example.com|
|Kaohsiung Veterans General Hospigal||Recruiting|
|Kaohsiung, Taiwan, 813|
|Contact: Wei-Lun Tsai, MD 886-7-3422121 ext 2075 firstname.lastname@example.org|
|Contact: Hi-Hung Chan, MD, PhD 886-7-3422121 ext 2074 email@example.com|
|Principal Investigator: Wei-Lun Tsai, MD|
|Kaohsiung Veterans General Hospital||Active, not recruiting|
|Kaohsiung, Taiwan, 813|