Status:
COMPLETED
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).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 resp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00442572
Start Date
July 3 2006
End Date
April 23 2012
Last Update
April 24 2025
Active Locations (1)
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1
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, Bulgaria, 1612