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

Withdrawn before enrolling · Not applicable

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT00715715

Run by

Maimonides Medical Center

People needed

0

Starts

2008-04-01

Expected to finish

2011-02-01

Last updated by the study team

2012-04-20

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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