UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014003 |
|---|---|
| Receipt number | R000016313 |
| Scientific Title | Simeprevir in combination with peginterferon and ribavirin theraphy for Japanese chronic HCV patients: Significance of hepatic transporter |
| Date of disclosure of the study information | 2014/05/21 |
| Last modified on | 2017/05/22 16:23:36 |
* 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
Simeprevir in combination with peginterferon and ribavirin theraphy for Japanese chronic HCV patients: Significance of hepatic transporter
Acronym
Hepatic transporter at simeprevir therapy
Scientific Title
Simeprevir in combination with peginterferon and ribavirin theraphy for Japanese chronic HCV patients: Significance of hepatic transporter
Scientific Title:Acronym
Hepatic transporter at simeprevir therapy
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship among hepatic transporter function, blood concentration of sipemrevir and hyperbilirubinemia by the quantification of transporter function with gadoxetic acid-enhanced MRI and the investigation of genetic polymorphisms in the organic transporting polypeptide genes
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between hyperbilirubinemia and gene polymorphisms in hepatic transporter
Key secondary outcomes
The relationship between blood concentration of sipemrevir and hepatic enhancement with gadoxetic acid
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)Peginterferon alfa-2a or 2b and ribavirin theraphy for genotype 1 and high viral titer chronic hepatitis C
2)Judged by investigator not to be appropriate for inclusion in this study
Key exclusion criteria
estimated glomerular filtration rate <40
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironao Okubo |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL
03-5923-3111
drokubo@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironao Okubo |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL
03-5923-3111
Homepage URL
drokubo@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Nerima Hospital
Department of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Urayasu Hospital
Department of Gastroenterology
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
| 2014 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 05 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016313
