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A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatment-resistant mutations or the durability of sustained virological response (SVR) in patients treated with DAA-containing regimens for chronic hepatitis C infection

Principal Investigator:   Albert Min, MD
Time frame of study:   Closed to enrollment, subjects still active
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Sara Lewis at 212-844-6408 or salewis@chpnet.org


Summary:
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.


Eligibility Participants:

  • At least 18 years of age
  • Participated in a specific investigational trial for Hepatitis C (Protocol R)5024048)
  • 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 dukim@chpnet.org