UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017823
Receipt No. 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

* 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 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
Email 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
Email kannos@pediatr.med.kyushu-u.ac.jp

Sponsor
Institute Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.