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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034785
Receipt No. R000039664
Official scientific title of the study Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration
Date of disclosure of the study information 2018/11/06
Last modified on 2018/11/06

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Basic information
Official scientific title of the study Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration
Title of the study (Brief title) Renal function of ETV continuation or switching to TAF in ETV administrating hepatitis B patients
Region
Japan

Condition
Condition Chronic hepatits B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and efficacy of the therapy of ETV (entecavir) continuation or switching to TAF (tenofovir alafenamide fumarate) in ETV administrating cases with chronic HBV infection with impaired renal function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Difference in estimated glomerular filtration rate (eGFR) between the 2 groups from 48 weeks, 96 weeks, and 144 weeks after randomization.
Key secondary outcomes Difference in changes HBV markers between the 2 groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuous administration of ETV
0.5 mg a day p.o. continuously
(Cases with prolonged dosing intervals due to renal impairment will continue as is.)
Interventions/Control_2 Switching to TAF
25 mg a day p.o. continuously
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HBV-infected patients who received ETV for more than 1 year and satisfy all of the following criteria.

1)eGFR is continuously 60 ml/min/1.73m2 or less.
2) ETV oral compliance is maintained.
3) The antiviral effect is well maintained. (HBV DNA <1.3 log IU/ml)
Key exclusion criteria 1) Patients with CCr (Cockcroft-Gault) less than 15 mL/min.
2) Patients who are concurrently administering with other nucleoside or nucleotide analogue.
3) Patients who the doctor in charge considers inappropriate as the subject in this study.
Target sample size 50

Research contact person
Name of lead principal investigator Yoshiyasu Karino
Organization Sapporo-Kosei General Hospital
Division name Department of Hepatology
Address 5 Kita 3 , Higashi 8, Chuo-ku, Sapporo
TEL 011-261-5331
Email shuhei.hige@ja-hokkaidoukouseiren.or.jp

Public contact
Name of contact person Shuhei Hige
Organization Sapporo-Kosei General Hospital
Division name Department of Hepatology
Address 5 Kita 3 , Higashi 8, Chuo-ku, Sapporo
TEL 011-261-5331
Homepage URL
Email shuhei.hige@ja-hokkaidoukouseiren.or.jp

Sponsor
Institute Sapporo-Kosei General Hospital
Department of Hepatology
Institute
Department

Funding Source
Organization self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌厚生病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 09 Month 18 Day
Anticipated trial start date
2018 Year 11 Month 06 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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