Last updated: 09/05/2022 07:00:06

TENOZET® Special Drug Use Investigation

GSK study ID
200726
See study documents
Clinicaltrials.gov ID
Not applicable
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: TENOZET® Special Drug Use Investigation
Trial description: This special drug use investigation will be conducted to collect and assess information regarding safety and emergence of hepatitis B virus (HBV)-resistant variants (virological breakthrough) up to a maximum of 240 weeks after the initiation of treatment with tenofovir and thereby to collect information regarding drug resistance and cross-resistance of the product.
TENOZET is a registered trademark of the GSK Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Clinical laboratory test

Timeframe: Up to a maximum of 240 weeks

Response rate based on the global assessment of effectiveness

Timeframe: Up to a maximum of 240 weeks

Occurrence of adverse drug reactions and infections in routine clinical practice

Timeframe: Up to a maximum of 240 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Tenofovir
    • Enrollment:
    300
    Primary completion date:
    2020-30-01
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Atsuko Ishida, Yuko Suzuki, Shigeomi Iimura, Toshiya Nandachi, Kenji Oda, Naohiro Takahashi, Daisaku Yasui. 200726: Safety of Long-term Administration of Tenofovir Disoproxil Fumarate Tablets in Patients With Hepatitis B Virus (HBV)-Related Chronic Liver Disease: Final Report of Special Drug Use Investigation (SDUI). Prog Med. 2021;41(9):899-910 DOI: NULL PMID:NULL
    Medical condition
    Hepatitis B
    Product
    tenofovir disoproxil fumarate
    Collaborators
    Not applicable
    Study date(s)
    September 2014 to January 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Not applicable
    • Patients who are diagnosed as having CHB
    • Patients who have participated in Japanese clinical studies of tenofovir (Studies LOC115409 and LOC115912) and continued treatment after the completion of the study, or participated in drug use investigation of tenofovir (200725) and continued treatment after the completion of the investigation
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients who are diagnosed as having CHB
    • Patients who have participated in Japanese clinical studies of tenofovir (Studies LOC115409 and LOC115912) and continued treatment after the completion of the study, or participated in drug use investigation of tenofovir (200725) and continued treatment after the completion of the investigation
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    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
    2020-30-01
    Actual study completion date
    2020-30-01

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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