Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:8/1/2018
Start Date:December 18, 2006
End Date:October 26, 2016

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Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

The purpose of this study is to prospectively assess the long-term outcomes (benefits and
risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for
the treatment of chronic HBV infection. For the China substudy, patients randomized to
entecavir will have safety and efficacy assessments performed during the first year of the
study.


Inclusion Criteria:

- Chronic HBV infection

- HBV nucleoside/tide-naive or -experienced

- Patients who, in opinion of investigator, are appropriate for initiating or modifying
their HBV therapy and who are appropriate for a treatment regimen comprised of
nucleoside/tide monotherapy with either ETV or another standard of care HBV
nucleoside/tide analogue

- Age 16 and older or minimum age required in a given country

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Patients who, in the opinion of the investigator, are expected to have a liver
transplant-free survival of less than one year

- Patients who, in the opinion of the investigator, are virologically controlled on
their current treatment regimen and clinically responding to treatment, unless the
regimen needs to be modified for medication intolerance

- Coinfection with HIV

- History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and
carcinoma in situ (CIS), but excluding non-melanoma skin cancers

- Patients with chronic renal insufficiency, defined as a creatinine clearance < 50
ml/min who do not have either of the following means of dose reducing ETV:

i. an approved country-specific ETV label which includes the extended interval ETV
dose modification method and/or ii. an approved country specific label for the ETV
oral solution AND access to the oral solution

- History of dysplastic liver nodules

- Known history of allergy to nucleoside/tide analogues

- Prior or current treatment with entecavir

- An investigator proposed study regimen which will include only interferon-alfa

- An investigator proposed study regimen of combination (two or more) HBV
nucleoside/tide analogues
We found this trial at
21
sites
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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New York, NY
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Atlanta, Georgia 30342
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Atlanta, GA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Ciudad De Buenos Aires, Buenos Aires
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Coronado, California 92118
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Coronado, CA
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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Flushing, New York 11355
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Flushing, New York 11355
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8900 Beverly Boulevard
Los Angeles, California 90048
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New York, New York 10010
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, FL
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19106
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Pittsburgh, Pennsylvania 15213
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San Francisco, California 94115
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