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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
Intervention Model: Parallel Assignment
Masking: None (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   (Adult)
Sexes Eligible for Study:   All
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

Keywords provided by GlaxoSmithKline:
Hepatitis B
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents processed this record on September 19, 2017