Trial information
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).
Status: Recruiting
Protocol number: ML20020
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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)
Brief summary: 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. Target sample size is
100.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Duration of treatment response (Serum HBV DNA <100,000 copies/mL) Time frame: After each treatment, and after 24 weeks of follow up
Key secondary outcomes: 1. Duration of treatment response Time frame: Every 12 weeks, and after follow-up.
2. Loss of HbsAg and seroconversion, and HBV DNA BLQ. Time frame: At end of follow up
3. Changes in liver fibrosis, AEs, lab parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- liver disease consistent with CHB;
- evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
- patients who have responded to previous 48 weeks treatment with interferon alfa.
Exclusion criteria:
- coinfection with HCV, HDV or HIV;
- decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2006
Trial registration date: 02/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Bulgaria
