UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017984 |
|---|---|
| Receipt number | R000020843 |
| Scientific Title | The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2022/12/24 11:36:11 |
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Basic information
Public title
The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders
Acronym
BezFAOD continuous clinical study
Scientific Title
The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders
Scientific Title:Acronym
BezFAOD continuous clinical study
Region
| Japan |
Condition
Condition
mitochondrial fatty acid beta-oxidation disorders
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the existence and its contents of adverse events and side effects caused by long-term administration of bezafibrate by the multicenter uncontrolled open-label trial for the subjects who completed the preceding study (HUPE-002-01 and HUPE-002-02) for the mitochondrial fatty acid beta-oxidation disorders (FAOD), are determined by a principal investigator or sub-investigator as beneficial to continue and also oneself wish to continue the clinical trial using bezafibrate.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Safety endpoint
Existence and its contents of adverse events and side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer orally the following daily doses, which are equivalent to the end of the preceding study (HUPE-002-02), of the investigational drug twice a day after breakfast and dinner.
(1) for ages 3 and older, under 7.5;
Standard treatment period: 200mg (morning: 100mg, evening: 100mg)
When dose increased: 300mg (morning: 200mg, evening: 100mg)
(2) for ages 7.5 to 11;
Standard treatment period: 300mg (morning: 200mg, evening: 100mg)
When dose increased: 400mg (morning: 200mg, evening: 200mg)
(3) for ages 12 and older;
Standard treatment period: 600mg (morning: 300mg, evening: 300mg)
When dose increased: 800mg (morning: 400mg, evening: 400mg)
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
| 3 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who:
(1) was enrolled in the preceding study (HUPE-002-02) and completed Week 78
(2) gives written informed consent before enrolling the study.
The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. Subjective patients under 20-year-old should receive an adequate explanation depending on one's ability to understand, and give assent with written forms if possible
Key exclusion criteria
Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Yamaguchi |
Organization
Shimane University Hospital
Division name
Department of Pediatrics
Zip code
693-8501
Address
89-1 En-ya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2220
seijiyam@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Yokoshiki |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical innovation Center Research and Development Division
Zip code
060-8648
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-7735
Homepage URL
Beza@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Hokkaido University Hospital Clinical Research Office
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道)、日本大学病院(東京都)、岐阜大学医学部附属病院（岐阜県）、大阪大学医学部附属病院（大阪府）、市立八幡浜総合病院（愛媛県）、鹿児島市立病院（鹿児島県）、久留米大学病院（福岡県）、筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 02 | 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
| Delay expected |
Results Delay Reason
Currently under construction and not yet completed.
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
| 2015 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020843
