Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection