Chronic Hepatitis B Clinical Trial
Official title:
A Phase 1b Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Initial Antiviral Efficacy of NVR 3-778 in Patients With HBeAg-Positive Chronic Hepatitis B Virus Infection
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.
The Phase 1b assessments of the dose-related safety, PK, and initial antiviral efficacy of
NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites
to meet enrollment goals of 54-84 chronic hepatitis B patients.
To promote objective safety and tolerance assessments during this trial, study subjects, and
site personnel administering the study drug and performing the clinical assessments on the
subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or
placebo doses), for all treatment cohorts in the study. Study advancement to subsequent
patient cohorts will require satisfactory interim reviews of available cumulative safety data
by the Safety Review Committees (SRC), using the safety criteria and review procedures
described in the protocol. Also, there will be one interim review of safety data by an
independent Safety Monitoring Board (SMB), as described in the protocol.
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