NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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).

NCT00442572

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis B, Chronic

Interventions: PEGASYS [peginterferon alfa-2a]

Countries: Bulgaria

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Sofia, Bulgaria