UMIN-CTR Clinical Trial

Basic information
Public title	DAA therapy and ADAMTS13/VWF for HCV
Acronym	DAA therapy and ADAMTS13/VWF for HCV
Scientific Title	DAA therapy and ADAMTS13/VWF for HCV
Scientific Title:Acronym	DAA therapy and ADAMTS13/VWF for HCV
Region	Japan

Condition
Condition	hepatitis type C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether ADAMTS13/VWF is associated with functional liver capacity for hepatitis C patients receiving DAA therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Portal hypertension
Key secondary outcomes

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)> 20 years old 2)The patients obtained the consent
Key exclusion criteria	1)The impossible of oral intake 2)The pharmacokinetics is changed for patient's condition 3)The necessary medicine change the pharmacokinetics of rifaximin 4)The pregnancy and lactating 5)The allergy of rifaximin 6)The outcome evaluation is difficult for patient's condition 7)The execution plan of achievement is difficult
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Takaya
Organization	Nara medical unversity
Division name	3rd departemnt of interanal medicine
Zip code	6348521
Address	840, Shijo-cho, Kashihara, Nara
TEL	0744223051
Email	htky@naramed-u.ac.jp

Public contact
1st name of contact person	1st name Hiroaki Middle name Last name Hiroaki
Organization	Nara medical unversity
Division name	3rd departemnt of interanal medicine
Zip code	6348521
Address	840, Shijo-cho, Kashihara, Nara
TEL	0744223051
Homepage URL
Email	htky@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Developmen
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara medical unversity
Address	840, Shijo-cho, Kashihara, Nara
Tel	0744223051
Email	htky@naramed-u.ac.jp

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	2020 Year 01 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2019 Year 05 Month 23 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041964