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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032073
Receipt No. R000036588
Scientific Title Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients -
Date of disclosure of the study information 2018/04/03
Last modified on 2019/10/12

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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 No longer recruiting
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

Other
Other related information

Management information
Registered date
2018 Year 04 Month 03 Day
Last modified on
2019 Year 10 Month 12 Day


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

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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