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

Primary Purpose

Chronic Hepatitis B

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prednisone Priming

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B e Antigen, HBeAg-positive chronic hepatitis B

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. For randomly selected patients not treated with steroids: The patients will receive 6 weeks of sugar pills (placebo) before taking Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study.

Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. 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. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study.

Outcomes

Primary Outcome Measures

The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.

Secondary Outcome Measures

Secondary efficacy end point is the proportion of patients with histologic improvement.

Full Information

NCT ID

NCT00715715

First Posted

July 11, 2008

Last Updated

April 18, 2012

Sponsor

Maimonides Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00715715

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn studies.

Study Start Date

April 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maimonides Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

Hepatitis B e Antigen, HBeAg-positive chronic hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. 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. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study.

Intervention Type

Drug

Intervention Name(s)

Prednisone Priming

Intervention Description

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.

Primary Outcome Measure Information:

Title

The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.

Time Frame

week 48

Secondary Outcome Measure Information:

Title

Secondary efficacy end point is the proportion of patients with histologic improvement.

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianjun Li, MD

Organizational Affiliation

Maimonides Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ting-Hui Hsieh, MD

Organizational Affiliation

Maimonides Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maimonides Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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