Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients
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 taking steroids, viral production usually increases and liver function tests
 increase. After stopping steroids, viral production usually decreases. Many studies in the
 past have studied taking a low dose steroid before treating hepatitis B. Those studies have
 shown that low dose steroids help your body to clear the virus. The goal of this study is to
 improve the liver function by slowing viral growth.
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 surface antigen (HBsAg) for at least 24 weeks before screening, evidence of
 chronic hepatitis on a baseline liver-biopsy sample obtained within 52 weeks before entry,
 evidence of HBV DNA by any commercial tests at least 4 weeks before screening, an high HBV
 DNA level (at least 20,000 IU/mL) at screening, and a high serum ALT level (1.0 to 5.0 times
 the upper limit of normal) at screening.

 This study involves experimental use of an approved drug (Prednisolone) on chronic hepatitis
 B patients. Patients will be involved in the study for up to 96 weeks from enrollment. There
 is no external sponsor, commercial sponsor nor federal agency on this study. The study will
 be conducted only at Maimonides Medical Center, its GI clinic and faculty practice. About 40
 subjects will be involved in the study overall. All the subjects will be filled up locally.
Inclusion Criteria:

 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 Criteria:

 -  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