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

August 31, 2005
October 15, 2008
April 2000
Not Provided
Proportion of patients with HBeAg seroconversion to anti-HBe
HBeAg seroconversion to anti-Hbe
Complete list of historical versions of study NCT00140725 on ClinicalTrials.gov Archive Site
  • 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
Sustained normalization of ALT undetectable HBV DNA histologic improvement YMDD mutants among the viremic relapsers at the end of therapy and safety of treatment
Not Provided
Not Provided
 
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
  • Drug: Lamivudine
    Other Names:
    • Lamivudine
    • Lamivudine plus Polyethylene glyco-interferon alfa-2b
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Not Provided
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00140725
NUC30938
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP