Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis B Virus (HBV) Infection-Immunology Sub-Study of ML18253
Status: No longer recruiting
Protocol number: ML18675
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A longitudinal analysis of PEGASYS on HBV-specific T cell responses in patients with HBeAg-negative chronic hepatitis B Infection-immunology sub-study of ML18253
Brief summary: This study will evaluate PEGASYS (peginterferon alfa-2a (40KD)) in patients with HbeAg-negative chronic HBV-Immunology Sub-Study of ML18253. The anticipated time on study treatment 3-12 months, and the target sample size is <100 individuals.
Target sample size is
15.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginteferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. CD4- and CD8-mediated immune responses, profile of pro-inflammatory cytokines, analysis of HBV viremia
Key secondary outcomes: 1. Safety: Adverse events, vital signs, and clinical laboratory parameters
Inclusion criteria:
- adult patients 18-55 years of age;
- chronic hepatitis B;
- liver disease consistent with chronic hepatitis;
- participation in study ML18253.
Exclusion criteria:
- interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy <=12 months before first dose of study drug;
- nonresponders to previous interferon therapy;
- co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
- hepatocellular cancer;
- compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Gender: Males or Females
Age limits: Min: 18 Years Max: 55 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 10/28/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
