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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:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00140725
First received: August 31, 2005
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  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
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:

U.S. FDA Resources

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 Names:
    • Lamivudine
    • Lamivudine plus Polyethylene glyco-interferon alfa-2b
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140725

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
HBeAg-positive
chronic
Hepatitis B
 lamivudine
seroconversion
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Interferon-alpha
 Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Lamivudine
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013