Trial information
A Study of PEGASYS (Peginterferon alfa-2a(40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B Virus (HBV).
Status: Completed
Protocol number: ML17700
Sponsor: Shanghai Roche Pharmaceuticals Ltd.
Company division: Pharmaceutical
Official Scientific Title: Effect of peginterferon alfa-2a (40 KD) (PEGASYS®) on viral response in patients with HBeAg-positive chronic hepatitis B
Brief summary: This is a study of the efficacy and safety of PEGASYS in naive, interferon- or lamivudine-pretreated patients with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
300.
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. Efficacy: percentage of patients with HBV DNA <100,000 copies/mL at end of follow-up; percentage of patients with HBeAg seroconversion at end of follow-up.
Key secondary outcomes: 1. Efficacy: HBV DNA below limit of detection, HBeAg loss and seroconversion, ALT normalisation, combined response (HBV DNA, HBeAg loss, and ALT normalisation) at end of treatment and end of follow-up. Safety: AEs, laboratory parameters, vital signs.
Inclusion criteria:
- adult patients 18-65 years of age;
- HBeAg-positive chronic HBV;
- treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion criteria:
- antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment;
- co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV);
- evidence of decompensated liver disease;
- 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
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Guangzhou
- Shanghai
