This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Novartis Investigator Site
Beijing, China
Novartis Investigator Site
Shatin, Hong Kong
Novartis Investigator Site
Taipo, Hong Kong
Novartis Investigator Site
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
Time frame: 48 weeks
Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b
Time frame: up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bialystok, Poland
Novartis Investigator Site
Lodz, Poland
Novartis Investigator Site
Warsaw, Poland
Novartis Investigator Site
Kaohsiung City, Taiwan
Novartis Investigator Site
Taipei, Taiwan
Novartis Investigator Site
Tau-Yuan County, Taiwan
Novartis Investigator Site
Bangkok, Thailand
...and 2 more locations