UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of the pharmacokinetics and adverse events of paritaprevir in patients with hepatitis C virus by magnetic resonance imaging
Title of the study (Brief title)	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	Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Department of Gastroenterology
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	Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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