Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients - Full Text View

Sponsor:	Maimonides Medical Center
Information provided by:	Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT00715715

Purpose

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.

Condition	Intervention
Chronic Hepatitis B	Drug: Prednisone Priming

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Prednisone Adefovir Adefovir dipivoxil Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:

The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT. [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy end point is the proportion of patients with histologic improvement. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 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.
Experimental: 2 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 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.

Arms

Assigned Interventions

No Intervention: 1

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.

Experimental: 2

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

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.

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715715

Locations

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219

Sponsors and Collaborators

Maimonides Medical Center

Investigators

Principal Investigator:	Jianjun Li, MD	Maimonides Medical Center
Principal Investigator:	Ting-Hui Hsieh, MD	Maimonides Medical Center

More Information

No publications provided

Responsible Party:	Jianjun Li, MD, Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT00715715 History of Changes
Other Study ID Numbers:	08-01-IVA6
Study First Received:	July 11, 2008
Last Updated:	February 4, 2009
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:

Hepatitis B e Antigen
HBeAg-positive chronic hepatitis B

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Prednisone

Adefovir dipivoxil
Adefovir
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012