Status:
UNKNOWN
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Conditions:
Chronic HBV With Severe Exacerbation
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
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% ...
Eligibility Criteria
Inclusion
- HBsAg (+) \> 6 months
- ALT \> 5X ULN
- Prolongation of prothrombin time \> 3 seconds and bilirubin level \> 2 mg/dl
- 20-75 years old
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01848743
Start Date
April 1 2013
End Date
October 1 2016
Last Update
September 16 2014
Active Locations (2)
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1
Kaohsiung Veterans General Hospigal
Kaohsiung, Taiwan, Taiwan, 813
2
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, Taiwan, 813