Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Status: Recruiting
Protocol number: ML20742
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study of the effect of Peginterferon alfa-2a (40KD) (PEGASYS®) plus entecavir (Baraclude®) combination therapy on quantitative changes in HBeAg in treatment-naive patients with HBeAg positive chronic hepatitis B
Brief summary: This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals. Target sample size is
210.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment. Time frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
Key secondary outcomes: 1. HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment. Time frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-65 years of age;
- HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
- absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion criteria:
- previous treatment for chronic hepatitis B within previous 6 months;
- antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
- co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
- history or other evidence of 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: December, 2007
Trial registration date: 01/30/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
China
- Beijing
- Hangzhou
- Shanghai
- Xi'An
- Zhengzhou
