Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hepatit...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for \>6 months, positive HBeAg, HBV DNA \>500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00435825
Start Date
March 1 2007
End Date
December 1 2010
Last Update
June 25 2013
Active Locations (55)
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1
Los Angeles, California, United States, 90095
2
Palo Alto, California, United States, 94304-1509
3
San Diego, California, United States, 92105
4
San Francisco, California, United States, 94115