Hepatitis B, Chronic Clinical Trial
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)
Verified date | October 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Bulgaria: Bulgarian Drug Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of treatment response (Serum HBV DNA <100,000 copies/mL) | After each treatment, and after 24 weeks of follow up | No | |
Secondary | Duration of treatment response | Every 12 weeks, and after follow-up. | No | |
Secondary | Loss of HbsAg and seroconversion, and HBV DNA BLQ. | At end of follow up | No | |
Secondary | Changes in liver fibrosis, AEs, lab parameters. | Throughout study | No |
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