UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients: a prospective study in real life settings.
Acronym	The efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients.
Scientific Title	Evaluation of the efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients: a prospective study in real life settings.
Scientific Title:Acronym	The efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients.
Region	Japan

Condition
Condition	cirrhotic and non cirrhotic patients with chronic hepatitis C virus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Identifying the predictive factors of virological response in glecaprevir and pibrentasvir treatment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	sustained virological response (SVR) at 12 week and 24 week after the end of treatment
Key secondary outcomes	incidence rate of adverse events sustained virological response (SVR) at 4 week after the end of 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	chronic hepatitis C and compensated cirrhotic patients with HCV RNA
Key exclusion criteria	decompensated cirrhosis
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fumitaka Suzuki
Organization	Toranomon Hospital
Division name	hepatology
Zip code
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Email	hitomis@mx1.harmonix.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Hitomi Sezaki
Organization	Toranomon Hospital
Division name	hepatology
Zip code
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Homepage URL
Email	hitomis@mx1.harmonix.ne.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

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

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

IRB Contact (For public release)
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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	虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 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	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	combination tablet of glecaprevir /pibrentasvir(100mg/40mg) three tablets once daily for 8 weeks or 12 weeks Evaluating the association with baseline characteristics (viral factors and host factors) and virological response.

Management information
Registered date	2018 Year 03 Month 10 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036166

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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