Status:
COMPLETED
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16+ years
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2016
Estimated Enrollment :
12522 Patients enrolled
Trial Details
Trial ID
NCT00388674
Start Date
December 18 2006
End Date
October 26 2016
Last Update
July 30 2018
Active Locations (290)
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1
Scti Research Foundation
Coronado, California, United States, 92118
2
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, United States, 90048
3
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
4
University Of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1845