Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Status: No longer recruiting
Protocol number: ML18495
Sponsor: Roche Korea
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of PEGASYS on HBV-DNA and ALT normalization in patients with HBeAg positive chronic hepatitis B
Brief summary: This study will evaluate the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B. All patients will receive PEGASYS 180 micrograms sc once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up. Target sample size is
146.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. HBV DNA <100,000 copies/mL, and loss of HBeAg, at week 72.
Key secondary outcomes: 1. Efficacy: ALT normalization, HBV DNA below limit of detection, combined response, HBeAg seroconversion and loss of HBeAg, at weeks 48 and 72. Safety: AEs, labs, vital signs.
Inclusion criteria:
- adult patients, 18-65 years of age;
- HBsAg +ve for >6 months, HBeAg +ve, AntiHBs -ve;
- detectable HBV DNA (>100,000 copies/mL).
Exclusion criteria:
- coinfection with hepatitis A, hepatitis C or HIV;
- evidence of decompensated liver disease;
- a medical condition associated with chronic liver disease other than viral hepatitis.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Korea, Republic of
