UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018406 |
|---|---|
| Receipt number | R000021308 |
| Scientific Title | Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2017/06/04 09:11:17 |
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Basic information
Public title
Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial
Acronym
Switching from entecavir to tenofovir for CHB patients with sustained viral supression
Scientific Title
Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial
Scientific Title:Acronym
Switching from entecavir to tenofovir for CHB patients with sustained viral supression
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring the reduction of hepatitis B surface antigen and the safety by switching from entecavir to tenofovir for patients who were treated with entecavir for more than one year and achieved sustained viral supression (HBV DNA levels < 3.0 logcopies/mL)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of patients who achieve the reduction of hepatitis surface antigen more than 0.5 log IU/mL for three years
Key secondary outcomes
1) The rates of negativity of hepatitis B e antigen for three years
2) The rates of negativity of hepatitis B surface antigen and achieving below 100 IU/mL or 1000 IU/mL of hepatitis B surface antigen levels for three years
Predictive factors of the reduction of hepatitis B surface antigen
3) The rates of viral breakthrough for three years
4) The chenges of serum creatinine and phosphate for three years
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tenofovir disoproxil fumarate 300mg/day daily
treatment period: 3 yaers
Interventions/Control_2
Entecavir 0.5mg/day daily
treatment period: 3 yaers
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients treated with entecavir for more than one year
Inclusion criteria as following;
1) Hepatits B surface antigen positive
2) HBV DNA levels < 3.0 log copies/mL for more than one year
3) Absence of renal impairment (serum creatinine levels <1.1mg/dL, eGFR >60 ml/min/1.73m2 and creatinine clearance >50ml/min)
4) Absence of hypophosphatemia (serum phosphate >2.8 mg/dL)
Key exclusion criteria
1) Hypersensitivity for tenofovir
2) Presence of renal impairment
3) Presence of hypophosphatemia
4) Poorly-controlled diabetes
5) Poorly-controlled hypertension
6) History of hepatocellular carcinoma
7) Ineligible patients by atending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Kumada |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
2-2-2 Toranomon Minato-ku Tokyo
TEL
03-3588-1111
kumahiro@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hosaka |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
2-2-2 Toranomon Minato-ku Tokyo
TEL
044-877-5111
Homepage URL
hosa-p@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
虎の門病院(東京都)、虎の門病院分院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021308
