Project Description:
This is a randomized, active-controlled, parallel-group, multi-site, open label study of PEG-Intron vs PEGASYS™ in IFN-treatment-naïve subjects with CHB. For ease in logistics, the current study includes both HBeAg(+) and HBeAg(-) subjects. However, each of these populations will be analyzed sepa . . .
Primary Outcomes:
For HBeAg(+) subjects:
The primary efficacy endpoint is the proportion of subjects achieving HBeAg
seroconversion at 24 weeks post-treatment. HBeAg seroconversion is defined as the loss of HBeAg and the presence of anti-HBe antibody.
For HBeAg(-) subjects:
The primary efficacy endpoint is the propo . . .
Key Inclusion and Exclusion Criteria:
Subjects with a diagnosis of CHB who are interferon-treatment-naïve and weigh ≥40 kg will be selected to participate in the trial. Decompensated liver disease, pre-existing psychiatric conditions, and co-infection with hepatitis C, hepatitis D, or HIV are considered exclusionary..
Countries of Recruitment:
Australia, Colombia, Hong Kong, Malaysia, Mexico, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied:
HBeAg positive chronic hepatitis B and HBeAg negative chronic hepatitis B