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
Finalized
Finalized
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
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. 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)

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