Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Status: Recruiting
Protocol number: ML20003
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effect of PEGASYS on treatment response in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B
Brief summary: This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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 150.
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 (HBeAg positive patients) Time frame: Week 96
2. HBV DNA <20,000 copies/mL (HBeAg negative patients) Time frame: Week 96
Key secondary outcomes: 1. HBV DNA <400 copies/mL, HbsAg seroconversion, ALT normalization, sustained HBe seroconversion in HBeAg positive patients. Time frame: Weeks 48 and 96
2. AEs and laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- HBV DNA >100,000 copies/mL.
Exclusion criteria:
- previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
- evidence of decompensated liver disease;
- history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- coinfection with hepatitis A, C or D, or HIV.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 06/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Russian Federation
- Chelyabinsk
- Ekaterinburg
- Irkutsk
- Kazan
- Krasnoyarsk
- Moscow
- Nizhny Novgorod
- Novokuznetsk
- Novosibirsk
- Rostov-Na-Donu
- Samara
- St Petersburg
- Stavropol
- Tomsk
- Tumen
- Ufa
- Volgograd
- Yakutsk
