UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031903 |
|---|---|
| Receipt number | R000036427 |
| Scientific Title | Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2023/03/30 12:57:17 |
* 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
Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B
Acronym
Effectiveness for switiching to tenofovir alafenamide
Scientific Title
Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B
Scientific Title:Acronym
Effectiveness for switiching to tenofovir alafenamide
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy, safety, and tolerability after switching from other nucleos(t)ide analogues to TAF for nucleos(t)ide analogue-experienced Japanese patients with chronic hepatitis B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients with virological response (HBV DNA level <2.1 log copies/mL) at weeks 24, 48, 96, 120 and 144 after switching from other nucleos(t)ide analogues to TAF
Key secondary outcomes
1.Changes from the baseline in hepatitis surface antigen levels
2.Changes from the baseline in serum alanine aminotransferase
3.Changes from the baseline in estimated glomerular filtration rate and urine beta-2 microglobulinuria
4.Changes from the baseline in albuminuria
5.Changes in spine-and hip-bone mineral density
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1.Patients with chronic hepatitis B and under treatment by nucleos(t)ide analogue(s) (lamivudine (LMV), adefovir dipivoxil (ADV), entecavir (ETV), and tenofovir disoproxil fumarate (TDF)), including compensated cirrhosis.
2.Patients with stable and well controlled hypertension, diabetes mellitus, heart diseases, CKD or risk of CKD (eGFR <60), and other patients whom Dr. consider appropriate to switch.
Key exclusion criteria
1.Patients with decompensated cirrhosis
2.Patients with co-infection of hepatitis C virus
3.Patients with co-infection of human immunodeficiency virus
4.Patients with stable estimated glomerular filtration rate <15 mL/min/1.73 m2
5.Patients with albumin <30 g/L and platelets <30,000
6.Patients with autoimmune hepatitis
7.Constant heavy alcohol drinkers (converted to ethanol over 60 g/day)
8.Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding
9.Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University Hospital
Division name
Kyushu University Liver Disease Study (KULDS)
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
e.ogawa.a65@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
e.ogawa.a65@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
Tel
092-642-5909
inenaga.tomomi.503@m.kyushu-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
