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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140725
First Posted: September 1, 2005
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140725


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00140725     History of Changes
Other Study ID Numbers: NUC30938
First Submitted: August 31, 2005
First Posted: September 1, 2005
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
HBeAg-positive
chronic
Hepatitis B
lamivudine
seroconversion
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
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
Interferons
Interferon-alpha
Lamivudine
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