Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B (CHB).
Status: Recruiting
Protocol number: WV19432
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of treatment duration and dose of PEGASYS on HBeAg seroconversion and safety in patients with HBeAg positive chronic hepatitis B.
Brief summary: This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms sc weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is
528.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. HBeAg seroconversion Time frame: At end of initial 24 week treatment-free follow-up.
Key secondary outcomes: 1. Loss of ABeAg, HBsAg seroconversion, loss of HBsAg, ALT, HBV-DNA. Time frame: At end of 24 week treatment-free follow-up, and at week 72.
2. HBeAg seroconversion Time frame: Week 72
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- positive HBsAg for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with CHB.
Exclusion criteria:
- antiviral therapy for CHB within previous 6 months;
- co-infection with HAV, HCV, HDV or HIV;
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 02/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
Brazil
- Campinas
- Ribeirão Preto
- Salvador
- Santo Andre
- Sao Paulo
China
- Beijing
- Guangzhou
- Hong Kong
- Hunan
- Shanghai
France
- Clichy
- Montpellier
- Nice
- Strasbourg
- Toulouse
- Villejuif
Germany
- Berlin
- Frankfurt Am Main
- Freiburg
- Köln
Korea, Republic of
New Zealand
Russian Federation
- Samara
- Smolensk
- St Petersburg
- Stavropol
Singapore
Taiwan
- Kaohsiung
- Kueishan
- Taipei
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
- Songkhla
United States
- Los Angeles, CA
- Palo Alto, CA
- San Diego , CA
- San Jose, CA
- Atlanta, GA
- Flushing, NY
- Portland, OR
- Richmond, VA
