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

NCT00715715 | Withdrawn

• 1 other identifier: 08-01-IVA6
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B e Antigen; HBeAg-positive chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

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

  week 48

Secondary Outcomes (1)

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

  Week 48

Study Arms (2)

1

NO INTERVENTION

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.

2

EXPERIMENTAL

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.

Drug: Prednisone Priming

Interventions

Prednisone Priming DRUG

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.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianjun Li, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

• Ting-Hui Hsieh, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Gastroenterology

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (1)