Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Lamivudine plus Polyethylene glyco-interferon alfa-2b (Drug); Lamivudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients with HBeAg seroconversion to anti-HBe
Secondary outcome: Normalization of alanine aminotransferase (ALT)Undetectable HBV DNA Histologic improvement Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Hong Kong, Hong Kong
Additional Information
Starting date: May 2000
Last updated: June 5, 2006
|
