NCT00715715

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

A Pilot Study of Adefovir Dipivoxil Alone and After Prednisone Priming for the Treatment of Asian Patients With HBeAg-positive Chronic Hepatitis B

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Prednisone Priming	For randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-07-15
• Last updated: 2012-04-20

Locations

1 site across 1 country: United States