Last updated: 11/07/2018 17:55:26

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

GSK study ID
NUC30938
See study documents
Clinicaltrials.gov ID
NCT00140725
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised trial of lamivudine plus interferon versus lamivudine for the treatment of HBeAg positive chronic hepatitis B virus (HBV)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
  • Drug: Lamivudine
    • Enrollment:
    160
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chan HL-Y, Leung NW-Y, Hui AY, et al. A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon ?2b and Lamivudine with Lamivudine Alone. Annals of Internal Medicine 2005:142 (4):240-251.
    Medical condition
    Chronic Hepatitis B
    Product
    lamivudine
    Collaborators
    Not applicable
    Study date(s)
    March 2000 to February 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    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.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Shatin, Hong Kong
    Status
    Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-23-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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