UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051192 |
|---|---|
| Receipt number | R000058264 |
| Scientific Title | Association of tenofovir disoproxil fumarate use with bone-related adverse events in chronic hepatitis B: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/05/30 |
| Last modified on | 2023/10/11 21:38:33 |
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Basic information
Public title
Association of tenofovir disoproxil fumarate use with bone-related adverse events in chronic hepatitis B: a systematic review and meta-analysis
Acronym
Association of tenofovir disoproxil fumarate use with bone-related adverse events in chronic hepatitis B: a systematic review and meta-analysis
Scientific Title
Association of tenofovir disoproxil fumarate use with bone-related adverse events in chronic hepatitis B: a systematic review and meta-analysis
Scientific Title:Acronym
Association of tenofovir disoproxil fumarate use with bone-related adverse events in chronic hepatitis B: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Patients with chronic hepatitis B using tenofovir disoproxil fumarate
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the incidence of bone-related adverse events for tenofovir disoproxil fumarate and other hepatitis B drugs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of fractures
Change in bone density before and after drug use
Change in percentage of patients with T-score below -2.5 before and after drug use
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic HBV infection (HBsAg positive for more than 6 months)
Serum ALT level greater than 60 U/L (men) or 38 U/L (women) and less than 10 times the upper limit of normal (ULN) at screening
Estimated creatinine clearance (CLCr) above 50 mL/min
Key exclusion criteria
Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
Coinfection with HCV, HIV or HDV
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Masago |
Organization
Hyogo Medical University
Division name
School of Pharmacy
Zip code
650-8530
Address
1-3-6 Minatojima, Kobe Chuo-ku, Hyogo
TEL
078-304-3000
dph2303@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Masago |
Organization
Hyogo Medical University
Division name
School of Pharmacy
Zip code
650-8530
Address
1-3-6 Minatojima, Kobe Chuo-ku, Hyogo
TEL
078-304-3000
Homepage URL
dph2303@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-3-6 Minatojima, Kobe Chuo-ku, Hyogo
Tel
078-304-3000
dph2303@hyo-med.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
| 2023 | Year | 05 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058264
