UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022587 |
|---|---|
| Receipt number | R000026037 |
| Scientific Title | Prediction of the pharmacokinetics and adverse events of paritaprevir in patients with hepatitis C virus by magnetic resonance imaging |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2018/02/26 07:34:40 |
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Basic information
Public title
Prediction of the pharmacokinetics and adverse events of paritaprevir in patients with hepatitis C virus by magnetic resonance imaging
Acronym
Prediction of the pharmacokinetics and adverse events of paritaprevir by MRI
Scientific Title
Prediction of the pharmacokinetics and adverse events of paritaprevir in patients with hepatitis C virus by magnetic resonance imaging
Scientific Title:Acronym
Prediction of the pharmacokinetics and adverse events of paritaprevir by MRI
Region
| Japan |
Condition
Condition
Type C chronic hepatitis or type C liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine whether magnetic resonance imaging enhanced by gadoxetic acid enhanced MRI can predict blood concentration of paritaprevir and adverse events
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
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 paritaprevir concentration determined 7 days after its administration.
Key secondary outcomes
To clarify the relationship among enhancement effect of Gd-EOB-DTPA,hepatic function, gene polymorphisms of hepatic transporter and 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
Genotype 1b chronic hepatitis C or compensated liver cirrhosis C patients using ombitasvir, paritaprevir and ritonavir. Genotype 2a chronic hepatitis C patients using ombitasvir, paritaprevir and ritonavir with ribavirin.
Key exclusion criteria
1) Y93 NS5A polymorphism (pretreatment resistance-associated variants) in the genotype 1b patients
2) Co-infection with hepatitis B or HIV
3) Evidence of viable hepatocellular carcinoma
4) Child-Pugh score greater than 7
5) Concurrent use of moderate to strong inducers of CYP3A and strong inducers of CYP2C8 reduce efficacy
6) Hypersensitivity to Gd-EOB-DTPA
7) Estimated glomerular filtration rate under 40ml/min/1.73m2
Target sample size
30
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
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
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
順天堂大学練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 06 | 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
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 20 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026037
