Last updated: 11/07/2018 04:44:18

Special Drug Use Investigation for ZEFIX (lamivudine) tablet (HBV Cirrhosis)

GSK study ID
112335
See study documents
Clinicaltrials.gov ID
NCT01376154
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: Special Drug Use Investigation for ZEFIX (lamivudine) tablet (HBV Cirrhosis)
Trial description: The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet

Timeframe: 6 months or more

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamivudine
    • Enrollment:
    342
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Atsuko Ishida, Yuki Saito, Hideyuki Okano, Terufumi Hara, Pascal Yoshida. Assessment of Safety and Efficacy of Lamivudine Tablets (Zefix® Tablets) Alone in Patients with Type B Cirrhosis Results of Special Drug Use Investigation for Long-Term Use. J Clin Therapeut Med. 2013;29(2):161-175.
    Medical condition
    Hepatitis B, Chronic
    Product
    adefovir, adefovir/lamivudine, lamivudine
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to January 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer
    • Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
    • Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer
    Exclusion criteria:
    • Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
    • Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2012-20-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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