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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00715715
• Other study ID #: 08-01-IVA6
• Status: Withdrawn
• Phase: N/A
• First received: July 11, 2008
• Last updated: April 18, 2012
• Start date: April 2008
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.		week 48	No
Secondary	Secondary efficacy end point is the proportion of patients with histologic improvement.		Week 48	No