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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022587
Receipt No. 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

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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
Email 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
Email drokubo@juntendo-nerima.jp

Sponsor
Institute Juntendo University Nerima Hospital
Department of Gastroenterology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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