UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C
Title of the study (Brief title)	Retreatment of Patients who failed DAAs with GLE/PIB+RBV
Region	Japan

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

Objectives
Narrative objectives1	we aimed to evaluate the efficacy and safety of GLE/PIB plus Ribavirin in Patients who previously failed Direct-acting antivirals; DAAs with chronic hepatitis C
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sustained virologic response 12 weeks after treatment
Key secondary outcomes	Virologic response at 2,4,8,12weeks and sustaind virologic response and safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orally administration of Glecaprevir(300mg)/Pibrentasvir(120mg) plus weight-based Ribavirin for 12 weeks
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	19 years-old <
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)chronic HCV genotype1-6 infection (HCV RNA detectable) 2)History of DAA-containing treatment, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B inhibitors 3)Those who received enough explanation for the participation in this study, and obtained written consent
Key exclusion criteria	1) Decompensated cirrhosis(jaundice,refractory ascites,hepatic encephalopathy,esophageal varices,spontaneous bacterial peritonitis) 2) Child-Pugh >6 at screening 3) Patients during treatment regardless of any type of cancer 4) Pregnancy or possible pregnancy and breast feeding 5) Patients with severe heart disease 6) Patients with haemoglobinopathies 7) The patients who meets even one any of the following, neutrophils less than 750 /mm3, platelet counts less than <50000 /mm3, Hb less than 10 g/dl 8) Patients with impaired renal function with chronic kidney failure or creatinine clearance less than 50 ml/min 9) Patient with severe mental diseases such as severe depression, the suicide consideration 10)Patients who cannot keep 6-month contraception after in the dosage and the dosage in the male patients that a partner may become pregnant 11)Patients who was judged to be inappropriate
Target sample size	10

Research contact person
Name of lead principal investigator	Tatehiro Kagawa
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterology
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	kagawa@tokai.ac.jp

Public contact
Name of contact person	Shunji Hirose
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterology
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	s-hirose@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	東海大学医学部付属病院（神奈川県） 東海大学医学部付属大磯病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 05 Day
Anticipated trial start date	2018 Year 03 Month 20 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

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036089