Hepatitis B Virus Clinical Trial
Official title:
Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive
At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious
for the treatment of chronic hepatitis B virus infection (CHB)
Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain
preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in
combination with Entecavir(ETV) to patients with hepatitis E antigen-positive
(HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach
Part B sub study is Open Label ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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