Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Status: Completed

Protocol Number: ML18092

Sponsor: Roche Bulgaria EOOD

Company Division: Pharmaceutical

Official Scientific Title: An open-label, non-randomized study to evaluate the effect of PEGASYS on HBV-DNA in patients with HBeAg-negative chronic hepatitis B infection

Brief Summary: This study will evaluate the efficacy, safety, and tolerability of PEGASYS in patients with HBeAg-negative chronic HBV. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 50.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Hepatitis B, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD)[PEGASYS]

Primary Outcome: 1. Efficacy: HBV-DNA <20,000 copies/mL at end of follow-up, normalization of ALT values at end of follow-up.Safety: AEs, laboratory parameters

Key Secondary Outcomes: 1. Efficacy: Loss of HBsAg and seroconversion at end of follow-up, HBV-DNA below limit of quantification at end of follow-up, HBV-DNA suppression <20,000 copies/mL at treatment end, ALT normalization at treatment end

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/28/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:48:54 PM