UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of glecaprevir/pibrentasvir combination tablets for patients infected with pan-genotypic hepatitis C virus
Acronym	Glecaprevir/pibrentasvir therapy for patients with HCV
Scientific Title	Efficacy and safety of glecaprevir/pibrentasvir combination tablets for patients infected with pan-genotypic hepatitis C virus
Scientific Title:Acronym	Glecaprevir/pibrentasvir therapy for patients with HCV
Region	Japan

Condition
Condition	Chronic Hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of glecaprevir/pibrentasvir combination tablets for patients infected with pan-genotypic hepatitis C virus, and analyze the viral factors associated with non-SVR.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rates of Sustained virological response at 12 and 24 weeks after the end of treatment
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	Patients infected with HCV
Key exclusion criteria	1) Patients who do not have consent to clinical research 2) Patietns accompanying HCC 2) Patients with pregnancy
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	3500495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL	049-276-1198
Email	smochida@saitama-med.ac.jp

Public contact
Name of contact person	1st name Yoshihito Middle name Last name Uchida
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	3500495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL	049-276-1198
Homepage URL
Email	y_uchida@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saitama Medical University
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel	049-276-1125
Email	hirb@saitama-med.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	2017 Year 11 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	200
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	Main results already published
Date of protocol fixation	2017 Year 11 Month 06 Day
Date of IRB	2017 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 06 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	obsevatinal cohort study.

Management information
Registered date	2017 Year 10 Month 22 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033884