Status:
WITHDRAWN
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients
Lead Sponsor:
Maimonides Medical Center
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taki...
Detailed Description
Asian patients who are older than 16 years of age and have HBeAg-positive chronic hepatitis B and good liver function will be entered in this study. Qualified patients also have positive hepatitis B s...
Eligibility Criteria
Inclusion
- This study is seeking patients with the following:
- Asians older than 16 years of age
- HBeAg-positive chronic hepatitis B, and
- Good liver function
- Positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening
- Liver biopsy in the past year showing of chronic hepatitis
- Blood testing showing HBV DNA in the past 4 weeks before screening
- Blood test showing high HBV DNA level (at least 20,000 IU/mL); AND
- Liver function test showing high serum ALT level (1.0 to 5.0 times the upper limit of normal).
Exclusion
- Ongoing drug abuse
- Active alcoholism
- Coinfection with hepatitis C, hepatitis D, or HIV
- Presence of other forms of liver disease
- Use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis B within 24 weeks before randomization
- Prior lamivudine therapy lasting more than 12 weeks
- Previous treatment with Adefovir dipivoxil
- AFP level greater than 100 ng/mL
- Decompensated liver disease
- History of ascites requiring diuretics or paracentesis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00715715
Start Date
April 1 2008
End Date
February 1 2011
Last Update
April 20 2012
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219