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

Completed

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT00388674

Run by

Bristol-Myers Squibb

People needed

12522

Starts

2006-12-18

Expected to finish

2016-10-26

Last updated by the study team

2018-07-30

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• University Of Connecticut Health Center — Farmington, Connecticut, United States
• University Of Miami Center For Liver Diseases — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Rush University Med Ctr — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Medical Procare, Pllc — Flushing, New York, United States
• Office Of Sing Chan Md — Flushing, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• Va New York Harbor Healthcare System — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Phgi Associates, Ltd — Philadelphia, Pennsylvania, United States
• Thomas Jefferson Medical College — Philadelphia, Pennsylvania, United States
• Upmc Center For Liver Diseases — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — El Palomar, Buenos Aires, Argentina
• Local Institution — San Salvador de Jujuy, Jujuy Province, Argentina
• Local Institution — Villa Nueva, Mendoza Province, Argentina
• Local Institution — Salta, Salta Province, Argentina
• Scti Research Foundation — Coronado, California, United States

Full record on ClinicalTrials.gov

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