Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2006

Trial Registration Date: 02/16/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:16:38 PM