Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Status: No longer recruiting
Protocol number: ML19295
Sponsor: Roche Products (New Zealand) Ltd
Company division: Pharmaceutical
Official Scientific Title: Expanded Access Program of PEGASYS® (Peg interferon alpha-2a (40 KD)) in patients with HBeAg-positive and HBeAg-negative chronic hepatitis B
Brief summary: This is an expanded access study to investigate the efficacy and safety of PEGASYS in New Zealand patients with HBeAG-positive and HBeAG-negative 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 individuals. Target sample size is
50.
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: HBeAg-positive patients <100,000 copies/mL at end of follow-up; HBeAg-negative patients <20,000 copies/mL at end of follow-up.
Key secondary outcomes: 1. HBV-DNA <400 cpm, HBsAg seroconversion, normalization of alanine aminotransferase (ALT), sustained HBe seroconversion (in HBeAg-positive patients only) at end of treatment and end of follow-up.
Inclusion criteria:
- adult 18-70 years of age;
- HBsAg-positive for >=6 months;
- anti-HBs-negative;
- baseline HBV DNA >500,000copies/mL for HBeAg-positive and >100,000copies/mL for HBe-Ag-negative patients;
- no previous antiviral treatment for HBV.
Exclusion criteria:
- previous antiviral or interferon therapy or treatment with a nucleoside analogue for chronic HBV infection;
- any condition consistent with decompensated liver disease;
- chronic liver disease other than viral hepatitis;
- co-infection with active hepatitis A, C, or D virus;
- co-infection with human immunodeficiency virus (HIV).
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2006
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
New Zealand
- Auckland
- Christchurch
- Hamilton
- New Plymouth
- Rotorua
