Status:
COMPLETED
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus...
Eligibility Criteria
Inclusion
- Adult participants, 18-70 years of age;
- HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
- anti-HBs negative;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
Exclusion
- Previous antiviral or interferon-based therapy for chronic hepatitis B;
- Evidence of 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00436163
Start Date
March 1 2007
End Date
May 1 2010
Last Update
October 24 2016
Active Locations (9)
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1
Tallinn, Estonia, 10138
2
Tallinn, Estonia, 10617
3
Tartu, Estonia, 51014
4
Riga, Latvia, 1006