Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Adefovir; Adefovir dipivoxil; Prednisone

Criteria

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