Status:
COMPLETED
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
- Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.
- Exclusion criteria:
- Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Exclusion
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00140725
Start Date
April 1 2000
Last Update
October 16 2008
Active Locations (1)
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1
GSK Investigational Site
Shatin, Hong Kong