Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

GlaxoSmithKline160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Chronic Hepatitis B

Interventions

Lamivudine plus Polyethylene glyco-interferon alfa-2bDRUG

LamivudineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

GSK Investigational Site

Shatin, Hong Kong

Outcomes

Primary Outcomes

Proportion of patients with HBeAg seroconversion to anti-HBe

Secondary Outcomes

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

Data from ClinicalTrials.gov

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