Last updated: 09/05/2022 06:20:06

TENOZET® Drug Use Investigation

GSK study ID
200725
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® Drug Use Investigation
Trial description: This investigation will be conducted to collect and evaluate information regarding the safety and effectiveness of tenofovir tablets under the actual post-marketing use conditions. In view of the risk for renal impairment in patients treated with tenofovir, renal toxicity will be collected as the priority investigation item to clarify the status of occurrence.
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:

Occurrence of adverse drug reactions and infections in routine clinical practice

Timeframe: 1 year

Response rate based on the global assessment of effectiveness

Timeframe: 1 year

Status of occurrence of renal toxicity

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Tenofovir
    • Enrollment:
    700
    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. 200725: Assessment of Safety and Effectiveness of Tenofovir Disoproxil Fumarate Tablets in Patients with Hepatitis B Virus-related Chronic Liver Disease - Final Results of Drug Use Investigation. Prog Med. 2021;41(9):889-897 DOI: NULL PMID: NULL
    Medical condition
    Hepatitis B
    Product
    tenofovir disoproxil fumarate
    Collaborators
    Not applicable
    Study date(s)
    December 2014 to January 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Not applicable
    • Patients who receive tenofovir for the first time
    • Tenofovir is used for suppression of HBV replication in patients with CHB with confirmed hepatic function abnormality associated with HBV replication
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients who receive tenofovir for the first time
    • Tenofovir is used for suppression of HBV replication in patients with CHB with confirmed hepatic function abnormality associated with HBV replication
    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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