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
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2020-30-01
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)

No location data available.

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
Finalized
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
Visit website