Back to resultsLamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Lamivudine plus Polyethylene glyco-interferon alfa-2b
Lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring HBeAg-positive, chronic, Hepatitis B, lamivudine, seroconversion, Chronic Hepatitis B
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Proportion of patients with HBeAg seroconversion to anti-HBe
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140725
Brief Title
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Official Title
A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
HBeAg-positive, chronic, Hepatitis B, lamivudine, seroconversion, Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lamivudine plus Polyethylene glyco-interferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Lamivudine plus Polyethylene glyco-interferon alfa-2b
Primary Outcome Measure Information:
Title
Proportion of patients with HBeAg seroconversion to anti-HBe
Secondary Outcome Measure Information:
Title
Normalization of alanine aminotransferase (ALT)
Title
Undetectable HBV DNA
Title
Histologic improvement
Title
Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
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