UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034251 |
|---|---|
| Receipt number | R000039041 |
| Scientific Title | Prediction of the pharmacokinetics and adverse events of glecaprevir/pibrentasvir in patients with hepatitis C virus by gadoxetic acid enhanced magnetic resonance imaging |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2021/09/26 11:07:27 |
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Basic information
Public title
Prediction of the pharmacokinetics and adverse events of glecaprevir/pibrentasvir in patients with hepatitis C virus by gadoxetic acid enhanced magnetic resonance imaging
Acronym
Prediction of the PKs and AEs of GLE/PIB by EOB-MRI
Scientific Title
Prediction of the pharmacokinetics and adverse events of glecaprevir/pibrentasvir in patients with hepatitis C virus by gadoxetic acid enhanced magnetic resonance imaging
Scientific Title:Acronym
Prediction of the PKs and AEs of GLE/PIB by EOB-MRI
Region
| Japan |
Condition
Condition
Type C chronic hepatitis or type C liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether enhancement effect of gadoxetic acid magnetic resonance imaging can predict the blood concentration of glecaprevir and adverse events
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the relationship between the pretreatment enhancement effect of Gd-EOB-DTPA MRI and the plasma glecaprevir concentration determined 7 days after its administration
Key secondary outcomes
To clarify the relationship between enhancement effect of Gd-EOB-DTPA MRI and development of hyperbilirubinemia during treatment.
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) chronic hepatitis C or compensated liver cirrhosis C patients using glecaprevir and pibrentasvir
Key exclusion criteria
1) Hypersensitivity to Gd-EOB-DTPA
2) Estimated glomerular filtration rate under 40ml/min/1.73m2
Target sample size
60
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
+81-3-5923-3111
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
+81-3-5923-3111
Homepage URL
drokubo@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2018 | Year | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 09 | Month | 24 | Day |
Last modified on
| 2021 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039041
