Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV infection: Realm Study (IRB#228-06)
||Albert Min, MD
frame of study:
||Closed to enrollment, subjects still active
||Mount Sinai Beth Israel
name, number and email
Duyang Kim at 212-844-6446 firstname.lastname@example.org
This study is looking at the long-term results associated with entecavir (ETV), a drug for treating Hepatitis B. Enrolled subjects will be randomized in a 1:1 ratio (50% chance of receiving either therapy) to an HBV treatment compromised of a single medication with either ETV or another standard of care HBV medication. Following randomization, the study will be observational. All patients will be followed for up to 10 years, with two visits per year, to assess clinical outcomes. Medication will be provided free of cost, as will the twice yearly visits. All other procedures will not be covered by the sponsor.
- At least 18 years of age
- Diagnosed with Hepatitis B
- Treatment Naive (have not previously been treated for Hepatitis B).
For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or email@example.com.