SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).
This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||'A Randomized, Open-label Study to Investigate the Effect on Sustained Virologic Response, and the Safety, of Intermittent Long Term Treatment With PEGASYS in Patients With HBeAg Negative Chronic Hepatitis B Who Have Responded to Previous Treatment With Interferon Alfa.' (SOFIA-LTT Study)|
- Duration of treatment response (Serum HBV DNA <100,000 copies/mL) [ Time Frame: After each treatment, and after 24 weeks of follow up ] [ Designated as safety issue: No ]
- Duration of treatment response [ Time Frame: Every 12 weeks, and after follow-up. ] [ Designated as safety issue: No ]
- Loss of HbsAg and seroconversion, and HBV DNA BLQ. [ Time Frame: At end of follow up ] [ Designated as safety issue: No ]
- Changes in liver fibrosis, AEs, lab parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Drug: peginterferon alfa-2a [Pegasys]
4 cycles of 135 micrograms sc weekly for 12 weeks followed by no treatment for 12 weeks.
|No Intervention: 2|