UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients -
Acronym	Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy
Scientific Title	Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients -
Scientific Title:Acronym	Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy
Region	Japan

Condition
Condition	Patients with chronic hepatitis C patients and patients with type C compensated cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effectiveness and safety of combination therapy of NS 3/4 A protease inhibitor Glecaprevir, NS 5 A inhibitor Pibrentasvir, and PK of the drug in hemodialysis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SVR 12 rate
Key secondary outcomes	1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration. 4. Drug concentration after administration in hemodialysis patients.

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	Case of chronic hepatitis C of genotype 1 or genotype 2: Three tablets once daily (300 mg as Glecaprevir and 120 mg as Pibrentasvir), orally administered after meals. The administration period is 8 weeks. C type compensatory cirrhosis of genotype 1 or genotype 2, or genotype 1 or genotype 2 chronic hepatitis C or type C compensated cirrhosis: Three tablets once daily (300 mg as Glecaprevir and 120 mg as Pibrentasvir), orally administered after meals. The administration period is 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	18 years-old <=
Age-upper limit	95 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who treated with Glecaprevir and Pibrentasvir combination therapy.
Key exclusion criteria	1.History of allergy to Glecaprevir / Pibrentasvir 2.Severe liver dysfunction 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Receiving contraindicated drugs for Glecaprevir and Pibrentasvir combined therapy
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1196
Address	1715,Kamakari,Inzai,Chiba, Japan
TEL	0476991111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1196
Address	1715,Kamakari,Inzai,Chiba, Japan
TEL	0476991111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital Organization Kyushu Medical Center St. Marianna University School of Medicine Shinmatusdo Central General Hospital Nippon Medical School Nippon Medical School Musashi Kosugi Hospital Otakanomori Hospital Tokyo Metropolitan Bokutoh Hospital Kitasato University School of Medicine Takamatsu Red Cross Hospital Ogaki Municipal Hospital Kagawa Prefectural Central Hospital Kikkoman General Hospital Tokyo Medical University Ibaraki Medical Center Osaka Medical College Nagoya City University Jikei University School of Medicine Juntendo University Shizuoka Hospital Ehime Prefectural Central Hospital Yokohama City University Medical Center Joban Hospital Masuko Memorial Hospital Okayama Saiseikai General Hospital Juntendo Nerima University Hospital Bantane Hospital, Fujita Health University School of Medicine Japanese Red Cross Ishinomaki Hospital Saiseikai Suita Hospital Saiseikai Niigata Daini Hospital Teine Keijinkai Hospital Mitoyo General Hospital Yashima General Hospital Kagawa University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Chiba Hokusoh Hospital Institutional Review Board
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
Tel	0476-99-1111
Email	araraki@nms.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

九州医療センター(福岡県）、聖マリアンナ医科大学（神奈川県）、新松戸中央総合病院（千葉県）、日本医科大学付属病院（東京都）、日本医科大学武蔵小杉病院（神奈川県）、おおたかの森病院（千葉県）、東京都立墨東病院（東京都）、北里大学（神奈川県）、高松赤十字病院（香川県）、大垣市民病院（岐阜県）、香川県立中央病院（香川県）、キッコーマン総合病院（千葉県）、東京医科大学茨城医療センター（茨城県）、大阪医科大学（大阪府）、名古屋市立大学（愛知県）、東京慈恵会医科大学（東京都）、東京慈恵会医科大学付属柏病院（千葉県）、順天堂静岡病院（静岡県）、愛媛県立中央病院（愛媛県）、横浜市立大学付属市民総合医療センター（神奈川県）、常磐病院（福島県）、増子記念病院（愛知県）、岡山済生会総合病院（岡山県）、順天堂練馬病院（東京都）、藤田保健衛生大学ばんたね病院（愛知県）、石巻赤十字病院（宮城県）、済生会吹田病院（大阪府）済生会新潟第二病院（新潟県）、手稲渓仁会病院（北海道）、三豊総合病院（香川県）、屋島総合病院（香川県）、香川大学（香川県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 03 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1200
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	2018 Year 01 Month 15 Day
Date of IRB	2017 Year 12 Month 13 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036588