Chronic HBV With Severe Exacerbation Clinical Trial
— HBSAEOfficial title:
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | October 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - HBsAg (+) > 6 months - ALT > 5X ULN - Prolongation of prothrombin time > 3 seconds and bilirubin level > 2 mg/dl - 20-75 years old Exclusion Criteria: - HAV, HCV, HDV and HIV co-infection - Concurrent hepatocellular carcinoma - Drug, metabolic or alcohol as cause of hepatitis - Anti-viral treatment in recent 6 mnths - Pregnant woman |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Kaohsiung Veterans General Hospigal | Kaohsiung | |
| Taiwan | Kaohsiung Veterans General Hospital | Kaohsiung |
| Lead Sponsor | Collaborator |
|---|---|
| Kaohsiung Veterans General Hospital. |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 6 months survival | 6 months survival after treatment begins | 6 months after treatment begins | No |
| Secondary | rapid virological response | Evaluate the relationship of rapid virological response ( at 1,2 and 4 weeks) and survival | 1,2 and 4 weeks after treatment | No |
| Secondary | HBeAg seroconversion and virological response 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 | 1,2 and 3 years after treatment | No |
| Secondary | Safety profile | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | during and 6 months after treatment | Yes |