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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 31, 2005
Last updated: October 15, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
Drug: Lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 160
Study Start Date: April 2000
Intervention Details:
    Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b Drug: Lamivudine
    Other Name: Lamivudine plus Polyethylene glyco-interferon alfa-2b

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00140725

Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00140725     History of Changes
Other Study ID Numbers: NUC30938 
Study First Received: August 31, 2005
Last Updated: October 15, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by GlaxoSmithKline:
Hepatitis B
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors processed this record on May 26, 2016