UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of the pharmacokinetics of asunaprevir in patients with hepatitis C virus by gadoxetic-acid-enhanced-magnetic resonance imaging
Title of the study (Brief title)	Pharmacokinetics of asunaprevir 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 clarify the relationship between hepatic enhancement with gadoxetic acid-enhanced MRI and the blood concentration of asunaprevir
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between hepatic enhancement with gadoxetic acid-enhanced MRI and the blood concentration of asunaprevir
Key secondary outcomes	The relationships among blood concentration of ASV, hepatic function, polymorphism of hepatic transporter, and adverse events.

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	Hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir
Key exclusion criteria	1) Y-93H NS5A polymorphism (pretreatment resistance-associated variants) 2) Co-infection with hepatitis B or HIV 3) Previous exposure to inhibitors of NS5A or NS3A protease 4) Evidence of viable hepatocellular carcinoma 5) Alanine aminotransferase of more than five times the upper limit of the normal range 6) Child-Pugh score greater than 7 7) Patients taking the following drugs:rifampicin,rifabutin,phenytoin, carbamazepine,phenobarbital,systemic administration of dexamethasone, St Johns wort 8) Hypersensitivity to gadoxetic acid 9) Estimated glomerular filtration rate under 40 mL/min/1.73m2
Target sample size	90

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	03-5923-3111
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	03-5923-3111
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

Other related organizations
Co-sponsor	1) Juntendo University Urayasu Hospital Department of Gastroenterology 2) Juntendo University Shizuoka Hospital Department of Gastroenterology
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） 順天堂大学浦安病院（千葉県） 順天堂大学静岡病院（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 30 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2015 Year 02 Month 28 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019343