UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017823 |
|---|---|
| Receipt number | R000020647 |
| Scientific Title | A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC) |
| Date of disclosure of the study information | 2015/06/05 |
| Last modified on | 2019/03/04 20:47:54 |
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Basic information
Public title
A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)
Acronym
A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)
Scientific Title
A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)
Scientific Title:Acronym
A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)
Region
| Japan |
Condition
Condition
Progressive familial intrahepatic cholestasis
Benign recurrent intrahepatic cholestasis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of rifampicin therapy for progressive familial intrahepatic cholestasis and benign recurrent intrahepatic cholestasis patients, when the standard treatments of cholestasis such as ursodeoxycholic acid and biliary drainage are ineffective.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum bilirubin and total bile acid
Key secondary outcomes
1. Laboratory blood test data at 1, 2, 4, 8 and 12 weeks after treatment (CBC, AST, ALT, gGTP, TP, Alb, T.Chol, LDL-C, PT, APTT, Ca, P, ALP, TSH, fT4, analysis of bile acids in serum).
2. Frequency of adverse events.
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
Rifampicin (RFP, 10 mg/kg/day) are given for 4-8 weeks.
When RFP is effective against cholestasis, RFP will be tapered 2.5mg/kg per a week and withdrawn after 4 weeks.
When bilirubin level does not decrease or the continuation of RFP is difficult for some side effects, RFP will be withdrawn.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Progressive familial intrahepatic cholestasis or benign recurrent intrahepatic cholestasis patients.
2. Patients whose written informed consent has been obtained (from them or from their parents).
Key exclusion criteria
1. Patients with past histories of hypersensitivity reaction against rifampicin.
2. Patients currently receiving medications that are known to interact with rifampicin (drug for HIV infection, voriconazole, pradicantel, tadalafil, telaprevir, or simeprevir etc.)
3. Patients with serious active bacterial infection as sepsis.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Ohga |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Pediatrics
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, 812-8582 Japan
TEL
092-642-5421
takadah@pediatr.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kanno |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Pediatrics
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city
TEL
092-642-5421
Homepage URL
kannos@pediatr.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 05 | 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
No patient was enrolled.
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
| 2013 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020647
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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