UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021948 |
|---|---|
| Receipt number | R000025301 |
| Scientific Title | Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2021/01/26 18:23:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection
Acronym
Tenofovir study in NA-treated patients with HBV
Scientific Title
Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection
Scientific Title:Acronym
Tenofovir study in NA-treated patients with HBV
Region
| Japan |
Condition
Condition
chronic HBV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this randomized control study, the entecavir-treated patients with chronic HBV infection are assigned to two groups: tenofovir-switch group and entecavir-continue group. Then we investigate the virological effects, the emergence rate of drug-resistant mutants, and the biochemical effects. The lamivudine/adefovir-teated patietns are assinged to two groups: lamivudine/tenofovir group and tenofovir alone group. Then we compare the efficacies as above.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The decline of HBsAg 2 years after the enrollment
Key secondary outcomes
The negativity of HBV DNA and HBeAg, and the normalization of ALT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch to tenofovir 300 mg/day in patients treated with entecavir 0.5 mg/day and observe for 2 years
Interventions/Control_2
Continue entecavir 0.5 mg/day in patients treated with entecavir and observe for 2 years
Interventions/Control_3
Switch to lamivudine 100 mg/day and tenofovir 300 mg/day in patients treated with lamivudine and adefovir 10 mg/day and observe for 2 years
Interventions/Control_4
Switch to tenofovir 300 mg/day alone in patients treated with lamivudine 100 mg/day and adefovir 10 mg/day and observe for 2 years
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
(1) Patients with chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year
(2) HBV DNA is less than 4.0 log copies/ml
(3) The liver disease is chronic hepatitis or compensated liver cirrhosis (up to Clid-Pugh grade A)
Key exclusion criteria
(1) Patients who is received interferon treatments
(2) Patients who is taking immunosuppressive agents
(3) Patients who have present or past hepatocellular carcinoma, or other malignant diseases
(4) Patients who have decompensated liver cirrhosis
(5) Patients who have renal dysfunction (eGFR is less than 50 ml/min/1.72m2)
(6) Patients who have low serum phosphorus (less than 2.5 mg/dl)
(7) Patients who are pregnant or have possibility of pregnancy
(8) Breast-feeding patients
(9) Patients who is infected also with HIV or HCV
(10) Patients who is participating other studies
(11) Patients who is considered inappropriate for this study by doctors in attendance
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Inoue |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi
TEL
022-717-7171
jinoue-drgn@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kakazu |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi
TEL
022-717-7171
Homepage URL
eijikakazu@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学病院（宮城県）、大曲厚生医療センター（秋田県）、岩手県立中央病院（岩手県）、気仙沼市立病院（宮城県）、石巻市立病院（宮城県）、東北労災病院（宮城県）、仙台赤十字病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025301
